For M Fd A 35 00a (10/05 )

Reporting 3500A.pdf

Guide for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drugs Without an Approved Application

FOR M FD A 35 00A (10/05 )

OMB: 0910-0636

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U.S. Department of Health and Human Services
Food and Drug Administration

For use by user-facilities,
importers, distributors and manufacturers
for MANDATORY reporting

MEDWATCH

General Instructions

FORM FDA 3500A (10/05)
2. Age at Time
of Event:

In confidence

Adverse Event

and/or

lbs
or

Male

B. ADVERSE EVENT OR PRODUCT PROBLEM

#1
#2

kgs

Section B - Help

3. Therapy Dates (If unknown, give duration)
from/to (or best estimate)

2. Dose, Frequency & Route Used
#1

Product Problem (e.g., defects/malfunctions)

2. Outcomes Attributed to Adverse Event
(Check all that apply)
Death:

FDA Use Only

Section C - Help

1. Name (Give labeled strength & mfr/labeler)

4. Weight
Female

UF/Importer Report #

C. SUSPECT PRODUCT(S)

3. Sex

Date
of Birth:

Mfr Report #

Page ____ of ____

Section A - Help

A. PATIENT INFORMATION
1. Patient Identifier

Form Approved: OMB No. 0910-0291, Expires: 10/31/08
See OMB statement on reverse.

5. Event Abated After Use
Stopped or Dose Reduced?
Doesn't
#1
No
Yes
Apply

4. Diagnosis for Use (Indication)
Disability or Permanent Damage

(mm/dd/yyyy)
Life-threatening

Congenital Anomaly/Birth Defect

Hospitalization - initial or prolonged

Other Serious (Important Medical Events)

#1
#2

8. Event Reappeared After
Reintroduction?

Yes

Doesn't
Apply

Yes

Doesn't
Apply

Required Intervention to Prevent Permanent Impairment/Damage (Devices)
3. Date of Event (mm/dd/yyyy)

4. Date of This Report (mm/dd/yyyy)

5. Describe Event or Problem

Yes

Doesn't
Apply

7. Exp. Date

6. Lot #

9. NDC# or Unique ID

PLEASE TYPE OR USE BLACK INK

10. Concomitant Medical Products and Therapy Dates (Exclude treatment of event)

Section D - Help

D. SUSPECT MEDICAL DEVICE
1. Brand Name
2. Common Device Name
3. Manufacturer Name, City and State

4. Model #

5. Operator of Device

Lot #

Health Professional
Expiration Date (mm/dd/yyyy)

Catalog #
Serial #

6. Relevant Tests/Laboratory Data, Including Dates

Other:

Other #

6. If Implanted, Give Date (mm/dd/yyyy)

Lay User/Patient

7. If Explanted, Give Date (mm/dd/yyyy)

8. Is this a Single-use Device that was Reprocessed and Reused on a Patient?
Yes

9. If Yes to Item No. 8, Enter Name and Address of Reprocessor

10. Device Available for Evaluation? (Do not send to FDA)
Yes

Returned to Manufacturer on:
(mm/dd/yyyy)

11. Concomitant Medical Products and Therapy Dates (Exclude treatment of event)
7. Other Relevant History, Including Preexisting Medical Conditions (e.g., allergies,
race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.)

E. INITIAL REPORTER
1. Name and Address

Submission of a report does not constitute an admission that medical
personnel, user facility, importer, distributor, manufacturer or product
caused or contributed to the event.

Section E - Help
Phone #

2. Health Professional? 3. Occupation
Yes

4. Initial Reporter Also Sent
Report to FDA
No
Unk.
Yes

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FDA USE ONLY

MEDWATCH
FORM FDA 3500A (10/05) (continued)

Section F - Help

Page ____ of ____

F. FOR USE BY USER FACILITY/IMPORTER (Devices Only)
1. Check One

2. UF/Importer Report Number
Importer

User Facility

Section H - Help

H. DEVICE MANUFACTURERS ONLY
1. Type of Reportable Event

3. User Facility or Importer Name/Address

2. If Follow-up, What Type?

Death

Correction

Serious Injury

Additional Information

Malfunction

Response to FDA Request

Other:

Device Evaluation

3. Device Evaluated by Manufacturer?

4. Device Manufacture Date
(mm/yyyy)

Not Returned to Manufacturer
5. Phone Number

4. Contact Person

6. Date User Facility or
Importer Became
Aware of Event (mm/dd/yyyy)

Yes

8. Date of This Report
(mm/dd/yyyy)

7. Type of Report

Evaluation Summary Attached
5. Labeled for Single Use?

No (Attach page to explain why not) or
provide code:

Yes

Initial
6. Evaluation Codes (Refer to coding manual)
Follow-up #

9. Approximate
Age of Device

10. Event Problem Codes (Refer to coding manual)

Method

Patient
Code

Results

Device
Code
11. Report Sent to FDA?

Conclusions
12. Location Where Event Occurred

(mm/dd/yyyy)

Home

Ambulatory
Surgical Facility

Nursing Home

13. Report Sent to Manufacturer?

Outpatient Treatment
Facility

Yes
No

Outpatient
Diagnostic Facility

Hospital

Yes

7. If Remedial Action Initiated, Check Type

(mm/dd/yyyy)

Recall

Notification

Initial Use of Device

Repair

Inspection

Reuse

Replace

Patient Monitoring

Relabeling

Other:

8. Usage of Device

Modification/
Adjustment

Unknown
9. If action reported to FDA under
21 USC 360i(f), list correction/
removal reporting number:

Other:

(Specify)
14. Manufacturer Name/Address
10.

Additional Manufacturer Narrative

and / or

11.

Corrected Data

Section G - Help

G. ALL MANUFACTURERS

1. Contact Office - Name/Address (and Manufacturing Site
for Devices)

2. Phone Number

3. Report Source
(Check all that apply)
Foreign
Study
Literature
Consumer
Health Professional
4. Date Received by
Manufacturer (mm/dd/yyyy)

User Facility

Company
Representative
Distributor

(A)NDA #
IND #

6. If IND, Give Protocol #

Other:

STN #
7. Type of Report
(Check all that apply)
5-day

30-day

7-day

Periodic

10-day

Initial

15-day

Follow-up # ____

9. Manufacturer Report Number

PMA/
510(k) #
Combination
Product

Yes

Pre-1938

Yes

OTC Product

Yes

8. Adverse Event Term(s)

The public reporting burden for this collection of information has been estimated to average 66
minutes per response, including the time for reviewing instructions, searching existing data
sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding this burden estimate or any other aspect of
this collection of information, including suggestions for reducing this burden to:

Department of Health and Human Services
Food and Drug Administration - MedWatch
10903 New Hampshire Avenue
Building 22, Mail Stop 4447
Silver Spring, MD 20993-0002
Please DO NOT RETURN this form to this address.

OMB Statement:
"An agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number."

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GENERAL INSTRUCTIONS

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•

All entries should be typed or printed in a font no
smaller than 8 point.

•

Complete all sections that apply. If information is
unknown, not available or does not apply, the section
should be left blank.

•

Dates should be entered as mm/dd/yyyy (e.g., June 3,
2005 = 06/03/2005). If exact dates are unknown,
provide the best estimate.

•

For narrative entries, if the fields do not provide
adequate space, attach an additional page(s).

The following specific information is to be incorporated:
• Include the phrase continued at the end of each
field of FDA Form 3500A that has additional
information continued onto another page

•

• Section G (All manufacturers) may be substituted
for section D (Suspect medical device) on the front
of the form to enable the submission of a one page
form
• If section G is reproduced on the front of the form it
must be an identical reproduction of the original
section G
•

All submissions must be made in English, including
foreign literature reports.

•

Vaccines: Events involving vaccines should be
reported to the Vaccine Adverse Event Reporting
System (VAERS) on form VAERS-1 (PDF format),
available at http://vaers.hhs.gov or by calling 1-800822-7967.

•

Devices: Federal law provides that user facility reports
that are required by law may not be used in private
civil litigation actions unless the party who made the
report had knowledge the report contained false
information. 21 USC 360i(b)(3).

• Identify all attached pages as Page __ of __
• Indicate the appropriate section and block number
next to the narrative continuation
• Display the User Facility, Distributor (Importer), or
Manufacturer report number in the upper right
corner as applicable
• Include the firm’s or facility’s name in the upper
right corner as well, if the report is from a user
facility, distributor (importer), or manufacturer

If no suspect medical device is involved in a reported
adverse event (i.e., when reporting ONLY a suspect
drug or biologic), ONLY sections A, B, C, E, and G
are to be filled out:

FRONT PAGE
At the top of the front page:

•

If the case report involves more than two (2) suspect
medications attach another copy of Form FDA
3500A, with only section C or section D filled in as
appropriate.
If the event involves more than one suspect medical
device, complete all applicable sections of Form FDA
3500A for the first device and a separate section D
(Suspect Medical Device) and Blocks F9, F10, F13,
and F14 for each additional device. Identify each
report as device 1, device 2, etc.
Manufacturers must complete and submit a separate
Form FDA 3500A for each different suspect device.
Each 3500A will be given a separate Manufacturer
Report Number.
If the suspect medical device is a single use device
that has been reprocessed for use in humans, then
the reprocessor is the manufacturer. The manufacturer can be either an Original Equipment Manufacturer (OEM), or a Reprocessor of Single-Use Devices,
which also can be a User Facility that reprocesses
Single-Use Devices. (See the table below)
Subject Device
Single Use Device
Device designed to be reused
Single Use Device, reprocessed for
reuse
Single Use Device, reprocessed by
Hospital or Health Care Facility

Manufacturer
Original Equipment Manufacturer
(OEM)
Original Equipment Manufacturer
(OEM)
Reprocessor
Hospital or Health Care Facility

Enter the page number and total number of pages
submitted (include attachments in the total) where
the words Page __ of __ are indicated.
On the top-right corner of the front page:
Enter the Manufacturer report number, User
Facility report number, or Distributor (Importer)
report number in the correspondingly labeled box
Enter both report numbers, if applicable, to crossreference this report with a report from another
source on the same event.
Mfr report #:
This is the unique identifier used by the manufacturer for this report. For a follow-up report,
the manufacturer report number must be identical
to the number assigned to the initial report. The
manufacturer report number is also entered in
block G9 on the back ofthe form.
For device manufacturers: The report number
consists of three components: the manufacturer’s
FDA registration number for the manufacturing site
of the reported device, the 4-digit calendar year,
and a consecutive 5-digit number for each report
filed during the year by the manufacturer (e.g.,
1234567-1997-00001,1234567-1997-00002).
(continued on next page)

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GENERAL INSTRUCTIONS (continued)

For drug and biologics, including human cell,
tissue, and cellular and tissue-based product
(HCT/P), manufacturers: The “mfr report #” is the
number the manufacturer chooses to uniquely
identify the report, and should conform to any
applicable regulations or guidances.
If submitting a follow-up to a report originally
obtained from FDA through a MedWatch to
Manufacturer Program , check the other box in
block G3 and enter the FDA-assigned report
number there.
UF/Dist report #:
This is the unique identifier used by the user
facility or the distributor (importer) for this report.
For a follow-up report, the UF/Dist report number
must be identical to the number assigned to the
initial report. The UF/Dist report number is also
entered in block F2 on the back of the form.
The user facility report number consists of three
components: the facility’s 10-digit Centers for
Medicare & Medicaid Services (CMS) number, the
4-digit calendar year, and a consecutive 4-digit
number for each report filed during the year by the
facility (e.g., 1234567890-1997-0001,12345678901997-0002). If the CMS number has fewer than 10
digits, enter ONLY these numbers, leaving the
remainder blank (zeros will be automatically filled
in by the system). If a facility does not have a CMS
number, the first report and any subsequent
reports should be submitted with all zeros in the
CMS space (e.g., 0000000000-1997-0001), and
FDA will assign a number to be used in future
reports. If a facility has more than one CMS
number, the facility must select one of those
numbers as the primary number and use it for
subsequent submissions.

If a user facility has multiple sites, the primary site
can report centrally and use one reporting number
for all sites IF the primary site provides the name,
address, and CMS number for each respective site.
The distributor (importer) report number consists of
three components: the FDA-assigned registration
or identification number for the distributor (importer)
of the device, the 4-digit calendar year, and a
consecutive 5-digit number for each report filed
during the year by the distributor (importer)
(e.g.,1234567-1997-00001, 1234567-1997-00002).
If a distributor (importer) does not have an
assigned identification number, it should use all
zeros in the appropriate space on the initial report,
and continue to use zeros on subsequent reports
until the FDA-assigned number is received. The
distributor (importer) would still enter the 4-digit
calendar year and 5-digit sequence number.
Note: In cases where a reporting site is registered as
both a manufacturer and a distributor (importer), and the
registration and/or FDA-assigned identification numbers
are identical for both, then the 5-digit sequence number
for reports submitted during the year by either one may
NOT be duplicated. For example, for devices manufactured by the firm, the report number would consist of
the registration number, calendar year, and a
consecutive 5-digit number (e.g., 1234567-1997-00001,
1234567-1997-00002, and so on). For devices distributed (imported) by the firm, the registration number
and year would remain the same, but the 5-digit
sequence number must be different (e.g., 12345671997-00003, 1234567-1997-00004, and so on).
BACK PAGE
At the top of the back page, enter the page number and
total number of pages submitted (include attachments in
the total) where the words Page __ of __ are indicated.

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SECTION A: PATIENT INFORMATION

Complete a separate form for each patient, unless the
report involves a medical device where multiple patients
were adversely affected through the use of the same
device.
In that case:
• Indicate the number of patients in block B5
(Describe event or problem)
• Complete separate section A and blocks B2, B5,
B6, B7, D11, F2 and F10 for each additional
patient
• Enter the corresponding patient identifier in block
A1for each patient involved in the event
Parent-child/fetus report(s) are those cases in which
either a fetus/breast feeding infant or the mother, or
both, sustain an adverse event that the initial reporter
considers possibly associated with a product administered to the mother during pregnancy. Several general
principles are used for filing these reports:
• If there has been no event affecting the child/fetus,
report only on the parent
• For those cases describing fetal death, miscarriage
or abortion, only a parent report is applicable
• When ONLY the child/fetus has an adverse
reaction/event (other than fetal death, miscarriage
or abortion ), the information provided in section A
applies to the child/ fetus, and characteristics
concerning the parent who was the source of
exposure to the product is to be provided in
section C.
•

•

When a newborn baby is found to have a congenital
anomaly/birth defect that the initial reporter considers
possibly associated with a product administered to
the mother during pregnancy, the patient is the
newborn baby.
If both the parent and the child/fetus sustain adverse
events, two reports should be provided and linked
using the narrative (include the manufacturer control
#’s in block B5)

A1: Patient identifier
Provide the patient’s initials or some other type of
identifier that will allow both the submitter and the initial
reporter (if different) to locate the case if contacted for
follow-up. Do not use the patient’s name or social
security number.
The patient’s identity is held in strict confidence by FDA
and protected to the fullest extent of the law. If no patient
was involved, enter none.
A2: Age at Time of Event or Date of Birth
Provide the most precise information available. Enter the
patient’s birthdate, if known, or the patient’s age at the
time of event onset. For age, indicate time units used
(e.g., years, months, and days).
• If the patient is 3 years or older, use years (e.g., 4
years)
• If the patient is less than 3 years old, use months
(e.g., 24 months)
• If the patient is less than 1 month old, use days
(e.g., 5 days)
• Provide the best estimate if exact age is unknown
A3: Sex
Enter the patient’s gender.
If the adverse event is a congenital anomaly, report the
sex of the child.
A4: Weight
Indicate whether the weight is in pounds (lbs.) or
kilograms (kgs). Make a best estimate if exact weight is
unknown.

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SECTION B: ADVERSE EVENT OR PRODUCT PROBLEM

B1: Adverse event and/or Product problem
Choose the appropriate box. Both boxes should be
checked if a product problem may have caused or
contributed to the adverse event.
Adverse event:
Any incident where the use of a medication (drug or
biologic, including human cell, tissue, or cellular or
tissue-based product (HCT/P), at any dose, or a medical
device (including in vitro diagnostics) is suspected to
have resulted in an adverse outcome in a patient.
Product problem (e.g., defects/malfunctions):
Any report regarding the quality, performance, or safety
of any medical product. This category is selected when
reporting device malfunctions that could lead to a death
or serious injury if the malfunction were to recur.

Life-threatening: Check if suspected that:
• The patient was at substantial risk of dying at
the time of the adverse event, or
• Use or continued use of the device might have
resulted in the death of the patient
Hospitalization (initial or prolonged): Check if
admission to the hospital or prolongation of hospitalization was a result of the adverse event.
DO NOT check if:
• A patient in the hospital received a medical
product and subsequently developed an otherwise nonserious adverse event, UNLESS the
adverse event prolonged the hospital stay
DO check if:
• A patient is admitted to the hospital for one or
more days, even if released on the same day

B2: Outcomes attributed to adverse event:
Indicate ALL that apply to the reported event:

• An emergency room visit results in admission to
the hospital

Drugs and Biologics: Only mark a box in this
section if the adverse event meets the regulatory
definition of serious in 21 CFR 314.80(a) and
600.80(a).

Note: Emergency room visits that do not result in
admission to the hospital should be evaluated for one of
the other serious outcomes (e.g., life-threatening; required intervention to prevent permanent impairment or
damage; other serious (medically important event)

Human Cells, Tissues, and Cellular and TissueBased Products (HCT/Ps): An adverse reaction
which is required to be reported to FDA is an adverse
reaction which involves a communicable disease and
by 21 CFR 1271.350a:

Disability or Permanent Damage: Check if the
adverse event resulted in a substantial disruption of a
person’s ability to conduct normal life functions.
Congenital anomaly/Birth Defect: Check if suspected
that exposure to a medical product prior to conception or during pregnancy may have resulted in an
adverse outcome in the child.

(i)

Is fatal;

(ii) Is life-threatening;
(iii) Results in permanent impairment of a body
function or permanent damage to body structure;
or
(iv) Necessitates medical or surgical intervention,
including hospitalization.
Death: Check if death was an outcome of the
adverse event, or if the cause of the death is
unknown. Include the date of death, if known.
DO NOT check if:
• The patient died while using a medical product,
but there was no suspected association
between the death and the use of the product
• A fetus is aborted because of a congenital
anomaly, or is miscarried

Required Intervention to Prevent Permanent
Impairment/Damage (Devices): if either situation
may be due to the use of a medical device and
medical or surgical intervention was necessary to:
• Preclude permanent impairment of a body function, or
• Prevent permanent damage to a body structure.
Other Serious (Important Medical Events):
• Check when, based on appropriate medical
judgement, the event may jeopardize the
patient and may require medical or surgical
intervention to prevent one of the other outcomes. Examples include allergic brochospasm
requiring emergency treatment, blood dyscrasias or convulsions that do not result in
hospitalization, or the development of drug
dependency or drug abuse. For human cells,
tissues, and cellular and tissue-based products
(HCT/P’s), such interventions could include
antibiotics in response to a positive culture or
clinical suspicion of an infection, but not as
prophylaxis for infection.
(continued on next page)

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SECTION B: ADVERSE EVENT OR PRODUCT PROBLEM (continued)

Devices: Check ONLY if the other categories are not
applicable to the event. Describe the patient outcome in the actual narrative of the event in block B5.
B3: Date of Event
Provide the actual or best estimate of the date of first
onset of the adverse event. If day is unknown, month
and year are acceptable. If day and month are unknown,
year is acceptable.
• When a newborn baby is found to have a
congenital anomaly, the event onset date is the
date of birth of the child
• When a fetus is aborted because of a congenital
anomaly, or is miscarried, the event onset date is
the date pregnancy is terminated.
If information is available as to time during pregnancy
when exposure occurred, indicate that information in
narrative block B5.

For a product problem: Describe the problem (quality,
performance, or safety concern) in sufficient detail so
that the circumstances surrounding the defect or
malfunction of the medical product can be understood. If
available, the results of any evaluation of a
malfunctioning device and, if known, any relevant
maintenance/service information should be included in
this section.
B6: Relevant
Dates:

Tests/Laboratory

Data,

Including

Provide all appropriate information, including relevant
negative test and laboratory findings, in order to most
completely convey how the medical work-up/assessment
led to strong consideration of medical-product-induced
disease as etiology for clinical status, as other differential diagnostic considerations were being eliminated.
Include:
• Any relevant baseline laboratory data prior to the
administration or use of the medical product

B4: Date of this Report
• Drugs and Biologics, including Human Cells,
Tissues, and Cellular and Tissue-Based
Products: The date the report is filled out.
• Devices: The date the initial reporter provided the
information about the event [i.e., the first person
or entity who initially provided the information to
the user facility, manufacturer, or distributor
(importer)].
B5: Describe Event or Problem
For an adverse event: Describe the event in detail
using the reporter’s own words, including a description of
what happened and a summary of all relevant clinical
information (medical status prior to the event; signs
and/or symptoms; differential diagnosis for the event in
question; clinical course; treatment; outcome, etc.). If
available and if relevant, include synopses of any office
visit notes or the hospital discharge summary. To save
time and space (and if permitted by the institution),
attach copies of these records with any confidential
information deleted. DO NOT identify any patient,
physician, or institution by name. The initial reporter’s
identity should be provided in full in section E.
Information as to any environmental conditions that may
have influenced the event should be included, particularly when (but not exclusive to) reporting about a
device.
• Results of relevant tests and laboratory data
should be entered in block B6. (see instructions for
B6).
• Preexisting medical conditions and other relevant
history belong in block B7. Be as complete as
possible, including time courses for preexisting
diagnoses (see instructions for B7).

• All laboratory data used in diagnosing the event
• Any available laboratory data/engineering analyses (for devices) that provide further information
on the course of the event
If available, include:
• Any pre- and post-event medication levels and
dates (if applicable)
• Synopses of any relevant autopsy, pathology,
engineering, or lab reports
If preferred, copies of any reports may be submitted as
attachments, with all confidential information deleted.
DO NOT identify any patient, physician or institution by
name. The initial’s reporter’s identity should be provided
in full in section E.
B7: Other Relevant History, Including Preexisting
Medical Conditions:
If available, provide information on:
• Other known conditions in the patient, e.g.,
• Hypertension
• Diabetes mellitus
• Renal/hepatic dysfunction, etc
• Significant history
•
•
•
•
•

Race
Allergies
Pregnancy history
Smoking and alcohol use
Drug abuse, etc.

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SECTION C: SUSPECT PRODUCT(S)

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For adverse event reporting, a suspect product is one that
the initial reporter suspected was associated with the
adverse event. In block C10 enter other concomitant
medical products (drugs, biologics, including human cells,
tissues, and cellular and tissue-based products (HCT/Ps),
and medical devices, etc.) that the patient was using at the
time of the event but are NOT thought by the initial reporter
to be involved in the event.

For human cells, tissues, and cellular and tissue-based
products HCT/Ps, provide the date of transplant and if
applicable, the date of explantation.
C4: Diagnosis for Use
Provide the indication for which the product was prescribed or used in this particular patient.
C5: Event Abated After Use Stopped or Dose Reduced:

Up to two (2) suspect products may be reported on one
form (#1=first suspect product, #2=second suspect
product). Attach an additional form if there were more than
two suspect products for the reported adverse event.
C1: Name:
Use the trade name as marketed. If unknown or if no trade
name, use the generic name (with the manu- facturer or
labeler’s name, if known). For foreign reports, use both the
foreign trade name and the U.S. generic name.
For human cells, tissues, and cellular and tissue-based
products (HCT/Ps), please provide the common name of
the HCT/P. You can also indicate if the HCT/P has a
proprietary or trade name. Examples: Achilles tendon, Iliac
crest bone, Islet Cells , or Brand X Bone Chips.

In addition to checking the appropriate box, provide
supporting lab tests and dates, if available, in block B6.
C6: Lot #:
If known, include the lot number(s) with all product problem
reports, or any adverse event report with a biologic or
medication.
C7: Expiration date:
Include with all product problem reports ONLY.
C8: Event Reappeared After Reintroduction:
In addition to checking the appropriate box, provide
supporting lab tests and dates, if available, in block B6.
C9: NDC # or Unique ID:

C2: Dose, Frequency & Route Used:
Describe how the product was used by the patient (e.g.,
500 mg QID orally or 10 mg every other day IV). For
reports involving overdoses, the amount of product used in
the overdose should be listed, NOT the prescribed amount.
• See APPENDIX for list of Routes of Administration
C3: Therapy Dates:
Provide the date administration was started (or best
estimate) and the date stopped (or best estimate). If no
dates are known, an estimated duration is acceptable (e.g.,
2 years) or, if therapy was less than one day, then duration
is appropriate (e.g., 1 dose or 1 hour for an IV).

The national drug code is required ONLY when reporting a
drug product problem. It can be found on the product label
and/or packaging. Zeros and dashes should be included as
they appear on the label.
If the product has a unique or distinct identification code,
please provide this here. Please provide the appropriate
tracking code for all human cells, tissues, and cellular and
tissue-based products (HCT/Ps)
C10: Concomitant Medical Products and Therapy
Dates:
List and provide therapy dates for any other medical
products (drugs, biologics, including HCT/Ps, or medical
devices, etc.) that a patient was using at the time of the
event. DO NOT include products used to treat the event.

APPENDIX - ROUTES OF ADMINISTRATION: ICH LIST AND CODES
Description ICH-M2 Numeric Codes
Auricular (otic) 001
Buccal 002
Cutaneous 003
Dental 004
Endocervical 005
Endosinusial 006
Endotracheal 007
Epidural 008
Extra-amniotic 009
Hemodialysis 010
Intra corpus cavernosum 011
Intra-amniotic 012
Intra-arterial 013
Intra-articular 014
Intra-uterine 015
Intracardiac 016
Intracavernous 017

Intracerebral 018
Intracervical 019
Intracisternal 020
Intracorneal 021
Intracoronary 022
Intradermal 023
Intradiscal (intraspinal) 024
Intrahepatic 025
Intralesional 026
Intralymphatic 027
Intramedullar (bone marrow) 028
Intrameningeal 029
Intramuscular 030
Intraocular 031
Intrapericardial 032
Intraperitoneal 033
Intrapleural 034

Intrasynovial 035
Intratumor 036
Intrathecal 037
Intrathoracic 038
Intratracheal 039
Intravenous bolus 040
Intravenous drip 041
Intravenous (not otherwise specified) 042
Intravesical 043
Iontophoresis 044
Occlusive dressing technique 045
Ophthalmic 046
Oral 047
Oropharingeal 048
Other 049
Parenteral 050
Periarticular 051

Perineural 052
Rectal 053
Respiratory (inhalation) 054
Retrobulbar 055
Sunconjunctival 056
Subcutaneous 057
Subdermal 058
Sublingual 059
Topical 060
Transdermal 061
Transmammary 062
Transplacental 063
Unknown 064
Urethral 065
Vaginal 066

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SECTION D: SUSPECT MEDICAL DEVICE

In block D11, report other concomitant medical products
(drugs, biologics, including human cells, tissues, and
cellular and tissue-based products (HCT/Ps), or medical
devices, etc.) that the patient was using at the time of the
event but are not thought to be involved in the event.
D1: Brand Name:
The trade or proprietary name of the suspect medical
device as used in product labeling or in the catalog (e.g.,
Flo-Easy Catheter, Reliable Heart Pacemaker, etc.). This
information may 1) be on a label attached to a durable
device, 2) be on a package of a disposable device, or 3)
appear in labeling materials of an implantable device.
Single use reprocessed devices may bear the OEM’s brand
name. If the suspect device is a reprocessed single-use
device, enter "NA".
D2: Common Device Name:
Use the Product Code assigned to the device based upon
the medical device product classification designated under
21 CFR Parts 862-892. Product codes may be found at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/
PCDSimpleSearch.cfm
If the product code is cannot be determined, use the
generic or common name of the suspect medical device or
a generally descriptive name (e.g., urological catheter,
heart pacemaker, patient restraint, etc.). Do not use broad
generic terms such as "catheter", "valve", "screw", etc.
D3: Manufacturer Name, City and State
If available, enter the full name, city, and state of the
manufacturer of the suspect medical device. If Block D8
below is ’Yes", enter the name, city and state of the
reprocessor.
D4: Model #, Catalog #, Serial #, Lot #, Expiration date
If available, provide any expiration date or any or all
identification numbers associated with the suspect medical
device exactly as they appear on the device or device
labeling. This includes spaces, hyphens, etc.
Model #: The exact model number found on the device
label or accompanying packaging
Catalog #: The exact number as it appears in the
manufacturer’s catalog, device labeling, or accompanying
packaging

D5: Operator of Device:
Indicate the type (not the name) of person operating or
using the suspect medical device on the patient at the time
of the event as follows:
•

Health professional = physician, nurse, respiratory
therapist, etc.

•

Lay user/patient = person being treated, parent/
spouse/friend of the patient

•

Other = nurses aide, orderly, etc.

D6: If Implanted, Give Date:
For medical devices that are implanted in the patient,
provide the implant date or best estimate. If day is
unknown, month and year are acceptable. If month and day
are unknown, year is acceptable.
D7: If Explanted, Give Date:
If an implanted device was removed from the patient,
provide the explant date or best estimate. If day is
unknown, month and year are acceptable. If month and day
are unknown, year is acceptable.
D8: Is this a Single-use Device that was Reprocessed
and Reused on a Patient?
Indicate "Yes" or "No"
If the original equipment manufacturer (OEM) is unable to
determine if their single use device was reprocessed and
reused on a patient, then the OEM should enter ’UNK’ in
Block D8 and in Block H10 (Additional Manufacturer
Narrative) describe the efforts made to obtain the
information and any responses.
D9: If Item No.8 is "Yes", Enter Name and Address of
Reprocessor:
Enter the name and address of the reprocessor of the
single-use device. Any entity that reprocesses single-use
devices for reuse in humans is the manufacturer of the
reprocessed single-use device.
D10 : Device Available for Evaluation?

Serial #: This number can be found on the device label or
accompanying packaging; it is assigned by the
manufacturer and should be specific to each device

Indicate whether the device is available for evaluation by
the manufacturer. Indicate if the device was returned to the
manufacturer and, if so, the date of the return. Do not send
the device to FDA.

Lot #: This number can be found on the label or packaging
material

D11 : Concomitant Medical Products and Therapy
Dates:

Expiration date: If available; this date can often be found
on the device itself or printed on the accompanying
packaging.
Other #: Any other applicable identification number (e.g.,
component number, product number, part number,
barcoded product ID, etc.)

List and provide product names and therapy dates for any
other medical products (drugs, biologics, including human
cells, tissues, and cellular and tissue-based products
(HCT/Ps), or medical devices, etc.) that the patient was
using at the time of the event. DO NOT include products
used to treat the event.

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SECTION E: INITIAL REPORTER

Indicate the person who initially reported the adverse
event to the user facility, distributor (importer), or
manufacturer.
E1: Name, Address & Phone #:
Please provide the name, mailing address, and phone
number of the person who initially reported the adverse
event to the user facility, manufacturer, or distributor
(importer), and who can be contacted to provide
information on the event if follow-up is necessary. If
available, provide reporter’s E-mail address and/or fax
number.

E2: Health Professional?:
Indicate whether the initial reporter is a health
professional (e.g., physician, pharmacist, nurse, etc.) or
not. If not a health professional, complete block E3 by
filling in NA.
E3: Occupation:
Indicate the initial reporter’s occupation (particularly type
of health professional), and include specialty if appropriate.
E4: Initial Reporter Also Sent Report to FDA:

For medical device reporting by user facilities, this
person may or may not be the designated medical
device reporting (MDR) contact.

Indicate whether the initial reporter also notified or
submitted a copy of this report to FDA.

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SECTION F: FOR USE BY USER FACILITY/IMPORTER - DEVICES ONLY

F1: Check one:

F8: Date of this Report:

Indicate whether the report is from a user facility or
importer.

Enter the date that the report was forwarded to the
manufacturer and/or the FDA.

F2: UF/Importer Report Number:

F9: Approximate Age of Device:

Enter the complete number of the report exactly as
entered in the upper right corner of the front page. For a
follow-up report, the UF/Importer report number must be
identical to the number assigned to the initial report. See
instructions on front page for further explanation of
UF/Importer report number.

Enter the age of the device or a best estimate (include
unit of time used: e.g., month, year).

F3: User Facility or Iimporter Name/Address:

Enter up to 3 "patient" and 3 "device" codes from the
Codes Manual that most accurately describe the event.
Patient codes describe what happened to the patient as
a result of the event and device codes describe device
failures or problems encountered during the event. If
more than 3 "patient" codes or more than 3 "device"
codes are needed, record them on a separate sheet,
mark it "F10", and provide the report number and page
number.

Enter the full name and address of the user facility or
importer reporting site.
F4: Contact Person:
Enter the full name of the medical device reporting
(MDR) contact person. This is the person designated by
the facility’s most responsible person as the device user
facility/importer contact for this requirement. FDA will
conduct its MDR correspondence with this individual.
The contact person may or may not be an employee of
the facility. However, the facility and its responsible
officials will remain the parties ultimately responsible for
compliance with the MDR requirements.
F5: Phone Number:
Enter the phone number of the MDR contact person.
F6: Date User Facility or Importer Became Aware of
Event:
Enter the date that the user facility’s medical personnel
or the importer became aware that the device has or
may have caused or contributed to the reported event.
F7: Type of Report:
Check the appropriate box to identify the type of report
being filed, i.e., an initial report of an event or a follow-up
to a previously submitted report. If a follow-up report,
make sure that the UF/ Importer report number for the
previously submitted initial report is recorded in block F2.
In the blank provided in block F7, record the appropriate
sequence of follow-up to that particular initial report (e.g.,
first follow-up report=follow-up #1, second follow-up
report=follow-up #2, and so on). Follow-up reports
should not repeat material that was submitted in the
initial report, but should ONLY provide additional or
corrected information on the previously reported event.

F10: Event Problem Codes (refer to Device Coding
Manual for Form 3500A):

If a user facility or an importer has reason to believe that
a reused device has or may have caused or contributed
to an adverse event, the device problem code 1537
("Reuse") should be entered in F10 along with any other
applicable device and/or patient-related codes.
F11: Report Sent to FDA?:
Check yes or no and indicate the date sent, if applicable.
F12: Location Where Event Occurred:
Check the location of the actual occurrence of the event.
If none of the designated location options apply, check
the other box and provide the location.
F13: Report Sent to Manufacturer?:
Check yes or no and indicate the date sent, if applicable.
F14: Manufacturer Name/Address:
Enter full name and address of the device manufacturer,
if available. If the manufacturer is a reprocessor of a
single-use device, the name and address should be
identical to the information in Block D9.

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SECTION G: ALL MANUFACTURERS

This section is to be filled out by all manufacturers.
NOTE: If a drug or biologic, including human cell, tissue,
and cellular and tissue-based product (HCT/P), manufacturer is reporting an adverse event in which no suspect
medical device is involved, section G may be identically
reproduced in place of Section D on the front of the form so
that a one page form may be submitted.
G1: Contact Office - Name/Address (and manufacturing
site for devices):
Enter the full name and address of the manufacturer
reporting site [contact office], including contact name. If the
manufacturing site of the device is not the same as the
contact office, enter site and the name and address of the
manufacturing site after the contact office name and
address.
G2: Phone Number:
Enter the telephone number of the contact office (devices)
or a representative knowledgeable about the report (drugs;
biologics, including HCT/Ps).
G3: Report Source:
Check the box(es) that most accurately describe(s) how the
manufacturer [contact office] became aware of the reported
adverse event or from where the information about the
adverse event originated.
• Foreign: Foreign sources include foreign governments, foreign affiliates of the application/license
holder, foreign licensors and licensees, foreign
medical facilities, etc. The country of origin should be
included.
• Study: Postmarketing, clinical trial, surveillance, or
other study that involves a systematic collection of
adverse events from a protocol designed specifically
to investigate product safety.
• Drugs and Biologics, including HCT/Ps: This
also includes information derived from planned
contacts and active solicitation of information from
patients (e.g., company-sponsored patient support
programs and disease management programs).
Applicants, manufacturers, and licensed manufacturers should not report safety information
obtained through these types of patient contacts
unless the adverse event meets the regulatory
definitions of serious and unexpected and there is
a reasonable possibility that the drug or biological
product caused the adverse experience. In
addition, manufacturers of human cells, tissues,
and cellular and tissue-based products (HCT/Ps)
are only required to report any adverse reaction
involving a communicable disease, if the adverse
reaction is fatal, life-threatening, results in permanent impairment to body structure or necessitates medical or surgical intervention including
hospitalization (effective May 25,2005).

• Literature: If the report source is the scientific
literature or an unpublished manuscript, a copy of the
article or manuscript must be attached. Foreign
language articles should be translated into English.
Record the date of the article as the date of the event
(block B3), and provide a full literature citation in block
H10. Drugs and Biologics, including HCT/Ps: A
separate 3500A form must be completed for each
identifiable patient described in the article or manuscript.
• Consumer (including attorneys): Additional information, whenever possible, should be sought from the
treating healthcare provider. A determined effort
should be made to obtain additional detailed information from health professionals for all serious
reactions, adverse events & product problems initially
reported by consumers. When this additional information is obtained, the follow-up report should check
health professional rather than consumer in block G3.
• Health professional: Physician, pharmacist, nurse,
etc.
• User facility: User facility should be checked if the
manufacturer received the report from the MDR
contact in a user facility as identified in section F. The
health professional should be listed as the initial
reporter on the front page of the form.
• Company representative: This check box would be
selected if a company representative reported the
event to the contact office based on information
received from a health professional. The health
professional should be listed as the initial reporter in
Section E.
• Distributor: This check box would be selected for a
report received from the distributor (importer) of the
suspect product. The health professional or other
reporter should be listed as the initial reporter on the
front page of the form.
• Other: Any source not covered by the previous
categories. For drug or biologic, including HCT/P
manufacturers, this check box would be selected
when submitting a follow-up to a report originally
obtained from FDA through a MedWatch to
Manufacturer program transmission of a serious direct
report, and the FDA-assigned report number entered
into the space provided. Other may also be used to
identify when the source is another manufacturer include the Manufacturer Report Number of the other
manufacturer.
G4: Date received by manufacturer: This means the date
when the applicant, manufacturer, corporate affiliate, etc.
receives information that an adverse event or medical
device malfunction has occurred. This would apply to a
report received anywhere in the world. (mm/dd/yyyy format)
• Follow-up reports: Use the date that the follow-up
information was received.
(continued on next page)

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SECTION G: ALL MANUFACTURERS (continued)

G5:
This block is for use by all manufacturers of drug, device,
biological products [including cell, tissue, and cellular and
tissue-based products (HCT/P)] and combination products.
Provide whatever information is applicable to the suspect
product identified in section C or suspect medical device
identified in Section D.
If the report lists two products by the same applicant as
suspect, the report should be submitted to the application
file of the product thought by the initial reporter to be the
more likely cause of the adverse event. If they are equally
suspect, the report should be submitted to the application
file of the product that is first alphabetically.

• 7-day: As specified in 21 CFR 606.170(b), blood
collection or blood transfusion fatalities should be
reported within 7 days of the fatality.
• 10-day: As specified in the device regulations, for
adverse event reports of death and serious injury from
user facilities.
• 15-day: As specified in the drug and biologic,
including human cell, tissue, and cellular and tissuebased product (HCT/P) regulations, for reports of
serious and unexpected adverse events.
• 30-day: As specified in device regulations, for initial
reports of a device that may have caused or contributed to a death or serious injury or for a device
malfunction that would be likely to contribute to a
death or serious injury if it were to recur.

• (A)NDA #: The abbreviated new drug application or
the new drug application (NDA) number. The report
should be filed to the first approved NDA if a product
has several NDAs and the specific one cannot be
determined.

• Periodic: As specified in the drug and biologic
regulations, for reports of serious labeled and
non-serious (labeled and unlabeled) adverse events.

• IND #: The investigational new drug (IND) application
number

• Initial: Check if the report is the first submission of a
manufacturer report. For devices, this is the 30-day
report.

• STN: The 6 digit product submission tracking number
(STN). If no STN exists, use the 4 digit U.S. License
Number.

• Follow-up: Check if the report is a follow-up to a
previously submitted report.

• PMA/510(k) #: The pre-market application (PMA) or
pre-market notification [510(k)] submission number for
the approved / cleared medical device or combination
product. If a product has several applicable PMA/
510(k)’s and the specific one cannot be determined,
then the first approved / cleared PMA or 510(k) number should be reported.
• Combination Product: Check the box if the suspect
product is comprised of a drug-device, devicebiological, drug-biological, or a drug-device-biological
product,
• Pre-1938: Check the box if the suspect medication
was marketed prior to 1938 and does not have an
NDA #.
• OTC Check the box if the suspect medication can be
purchased over-the-counter (without a prescription).
G6: If IND, Protocol #: This block is for use by drug and
biologic, including HCT/P manufacturers ONLY. If the form
is being used as a written IND safety report, enter the
protocol number.
G7: Type of Report: Select ALL the check boxes that
apply to reported event:
• 5-day: As specified in the device regulations, for
reports of adverse events that necessitate remedial
action to prevent an unreasonable risk of substantial
harm to the public health, or are required by FDA by
written notice.

• Follow-up reports on devices should NOT repeat
material that was submitted in the initial report, but
should ONLY provide additional or corrected
information on the previously reported event.
Follow-up reports on drugs and biologics, including
HCT/Ps, should contain information that was
submitted in the original report if the information is
still correct.
• If a follow-up report, make sure that the manufacturer report number for the previously submitted
initial report is recorded in block G9. In the blank
provided in block G7 after follow-up, record the
appropriate sequence of follow-up to that particular
initial report (e.g., first follow-up report=follow-up
#1, second follow-up report=follow-up #2, and so
on).
• For drug and biologic, including HCT/P manufacturers: If submitting a follow-up to a report
originally obtained from FDA through a MedWatch
to Manufacturer program transmission of a serious
direct report, check the other box in block G3 and
enter the FDA-assigned report number there.
G8: Adverse Event Term(s) [for use by drug and biologic,
including human cell, tissue, and cellular and tissue-based
product (HCT/P), manufacturers only]:
Include a list of adverse event terms that most accurately
characterize the adverse event described in narrative format
in block B5. Terms should be listed with the most important
term(s) first. The terminology may be an accepted standard
(e.g., MEDDRA or WHOART), a verbatim term, or the
manufacturer’s own terminology.
(continued on next page)

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SECTION G: ALL MANUFACTURERS (continued)

G9. Manufacturer Report Number

For human cell, tissue, and cellular and tissue-based
product (HCT/P) manufacturers:

For all manufacturers:
Enter the Manufacturer report number exactly as it appears
in the “Mfr Report #” field in the upper right corner of the first
page. For a follow-up report, the Manufacturer report
number must be identical to the number assigned to the
initial report .
For drug and biologic manufacturers:
The manufacturer report number is the number the
manufacturer chooses to uniquely identify the report, and
should conform to any applicable regulations or guidances.
If submitting a follow-up to a report originally obtained from
FDA through a MedWatch to Manufacturer program
transmission of a serious direct report, check the other box
in block G3 and enter the FDA-assigned report number
there.

The report number should consist of three numbers
separated by dashes. The first number will be the 10-digit
FDA Establishment Identifier (FEI) number, which was
assigned to you as part of the Human Cells and Tissue
Establishment Registration (HCTERS). The second number
should be the year that you are submitting the report. The
last number should be a consecutive 5-digit number for
each report filed during the year by the manufacturer.
Example: 1234567890-2005-00005.

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SECTION H: DEVICE MANUFACTURERS ONLY

H1: Type of Reportable Event:

H6: Evaluation Codes:

Check the appropriate box. These choices represent the
categories of events that device manufacturers are required
to report.

Enter the applicable codes from the codes manual for one
or more of the categories listed. Conclusion codes must be
entered even if the device was not evaluated.

Death: Check ONLY if the death was an OUTCOME of
the adverse event.

If the reuse of a device may have caused or contributed to
the adverse event, then the appropriate manufacturer
Result codes are to be entered from the codes manual.
Applicable reuse codes are 230-233 and may be used
alone or with any other applicable results codes. (see H8).

Serious injury: An adverse event that is lifethreatening; results in permanent impairment of a
body function or permanent damage to a body structure;
or necessitates medical or surgical intervention to
preclude permanent impairment of a body function or
permanent damage to a body structure.
Malfunction: See the guidelines. ("See the guidelines"
refers to the applicable sections in 21 CFR Part 803
reporting guidelines associated with device malfunctions).
Other: This option is intended to capture reports that
the manufacturer believes the agency should be aware
of that are not covered by death, serious injury, or
malfunction as these terms are defined by the statute,
regulation, or guidelines. This type of event category
should be rarely used
H2: If Follow-up, What Type?:
Check the box(es) that most accurately describes the
nature of the follow-up report.
Correction: Changes to previously submitted information.
Additional information: Information concerning the
event that was not provided in the initial report because
it was not known/available when the report was
originally submitted.

H7: If Remedial Action Initiated, Check Type:
Indicate the applicable action(s). If other, specify the type of
action in the space provided. Most of these terms are
defined or further explained in the Act or in the FDA
regulations concerning remedial action (see 21 USC 360h
and 21 CFR Parts 7, 803 and 806).
H8: Usage of Device:
Indicate whether the use of the suspect medical device was
the initial use, reuse, or unknown. If a manufacturer
receives an adverse event report that indicates that the
event was caused by or contributed to by reuse of a single
use device they manufactured, this block is to be
appropriately marked and the facts of the firm’s investigation provided with an explanation of how the reuse of the
product contributed to the outcome. The appropriate manufacturer Result codes for reuse are also to be entered into
H6.
H9: If action reported to FDA under 21 USC 360i(f), list
correction/removal reporting number:
Enter the number that FDA assigned to the corrective
action. If a number has not yet been assigned by FDA, the
number assigned by the firm for the action may be used.

Response to FDA request: Additional information
requested by FDA concerning the device/event.

H10: Additional Manufacturer Narrative:

Device evaluation: Evaluation/analysis of device.

Enter any additional information, evaluation, or clarification
of data presented in previous sections. Do NOT duplicate
information that has already been provided elsewhere.

H3: Device Evaluated by Manufacturer?:
Check the box marked not returned to mfr. if an
evaluation could not be made because the device was not
returned to, or made available to, the manufacturer. Check
the box marked yes if an evaluation was made of the
suspect or related medical device. If an evaluation was
conducted, attach a summary of the evaluation and check
the box marked evaluation summary attached. If an
evaluation of a returned suspect or related medical device
was not conducted, check the box marked no and attach a
page to explain why not or provide the appropriate code
from the codes manual in the space provided.
H4: Device Manufacture Date:
Enter the month and year of manufacture of the suspect
medical device using a MM/YYYY date format.

H11: Corrected Data:
Provide the following additional, corrected, or missing information, identifying each data item by the applicable section
and block number:
1. Any information missing on the user facility or
distributor (importer) report, including any missing or
incomplete event codes required by block F10
2. Information corrected on the user facility or distributor
(importer) report form after verification, including any
corrected event codes required by section D (e.g.,
D6: model number)

H5: Labeled for Single Use?:

3. For each event provided in block F10, an indication
of whether the type of event represented by the code
is addressed in the device labeling, and

Indicate whether the device was labeled for single use or
not. If the question is not relevant to the device being
reported (e.g., an X-ray machine), check no.

4. An explanation of why any required information was
not provided and the steps taken to obtain such
information.

File Type	application/pdf
File Title	Adobe:FDA-3500A_8-02-05.IFD
Author	bdoyle
File Modified	2007-10-25
File Created	2005-10-17