Form FDA 3500 FDA 3500 MedWatch for VOLUNTARY reporting of adverse events, prod

Form Approved: OMB No. 0910-0291, Expires: 6/30/2015
See PRA statement on reverse.

For VOLUNTARY reporting of
adverse events, product problems and
product use errors

U.S. Department of Health and Human Services

MEDWATCH
The FDA Safety Information and
Adverse Event Reporting Program

FDA USE ONLY
Triage unit
sequence #
FDA Rec. Date

Page 1 of

Note: For date prompts of “dd-mmm-yyyy” please use 2-digit day, 3-letter month
abbreviation, and 4-digit year; for example, 01-Jul-2015.

3. Dose or Amount
#1

Frequency

Route

A. PATIENT INFORMATION
1. Patient Identifier

2. Age

Year(s)

Month(s) 3. Sex

Week(s)

Days(s)

4. Dates of Use (From/To for each) (If unknown,
give duration, or best estimate) (dd-mmm-yyyy)
#1

lb

Male

24-Mar-2015

In Confidence
5.a. Ethnicity (Check
single best answer)

NNN.N
format

Female

or Date of Birth (e.g., 08 Feb 1925)

#2

4. Weight

kg

5.b. Race (Check all that apply)
Asian

Black or African American

Not Hispanic/Latino

Native Hawaiian or Other Pacific Islander

5. Diagnosis or Reason for Use (indication)
#1 The entry field will allow for two lines of

White

entry text at about this size.

B. ADVERSE EVENT, PRODUCT PROBLEM
Adverse Event

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

Product Use Error

Problem with Different Manufacturer of Same Medicine

2. Outcome Attributed to Adverse Event (Check all that apply)

PLEASE TYPE OR USE BLACK INK

Include date (dd-mmm-yyyy):

25-Apr-2015

Life-threatening

Disability or Permanent Damage

Hospitalization – initial or prolonged

Congenital Anomaly/Birth Defects

PR

(Continue on page 3)
6. Relevant Tests/Laboratory Data, Including Dates

7. Is the Product Overthe-Counter?

#1

Yes

No

#1

Yes

No

#2

Yes

No

#2

Yes

No

-

-

al on

(Continue on page 3)
7. Other Relevant History, Including Preexisting Medical Conditions (e.g.,
allergies, pregnancy, smoking and alcohol use, liver/kidney problems, etc.)

(Continue on page 3)

-

#2

Yes

No

Doesn’t
apply

#1

Yes

No

Doesn’t
apply

#2

Yes

No

Doesn’t
apply

-

1. Brand Name

2. Common Device Name

2b. Procode

3. Manufacturer Name, City and State

5. Operator of Device

4. Model #

Lot#

Catalog #

Expiration Date (dd-mmm-yyyy)

-

Returned to Manufacturer on (dd-mmm-yyyy)

-

6. If Implanted, Give Date (dd-mmm-yyyy)

-

Removed
“Specify”

This entry line now has
no visual prompt.
7. If Explanted, Give Date (dd-mmm-yyyy)

-

-

8. Is this a single-use device that was
reprocessed and reused on a patient?

-

Yes

No

9. If Yes to Item 8, Enter Name and Address of Reprocessor

F. OTHER (CONCOMITANT) MEDICAL PRODUCTS

-

(Continue on page 3)

G. REPORTER (See confidentiality section on back)

D. SUSPECT PRODUCTS

1. Name and Address

1. Name, Manufacturer/Compounder, Strength (from product label)

Last Name:

#1 – Name and Strength

#1 – NDC # or Unique ID

Address:

#1 – Manufacturer/Compounder

#1 – Lot #

First Name:

State/Province/Region:

City:
Country:

ZIP/Postal Code:

Phone #:

Email:

#2 – Name and Strength

#2 – NDC # or Unique ID

2. Health Professional?

#2 – Manufacturer/Compounder

#2 – Lot #

5. If you do NOT want your identity disclosed
to the manufacturer, please mark this box:

Yes

FORM FDA 3500 (5/15)

Other

Product names and therapy dates (Exclude treatment of event)

C. PRODUCT AVAILABILITY
No

Lay User/Patient

-

2. Product Available for Evaluation? (Do not send product to FDA)
Yes

Health
Professional

Unique Identifier (UDI) #

Serial #

Buttons are not function
layout design proof.

#2

F
O
O

06 -Nov -2016

Designer note: This is a “layout design” proof of this
form. Entry fields and 508-compliance features will be
added after this design is approved.

Doesn’t
apply

E. SUSPECT MEDICAL DEVICE

4. Date of this Report (dd-mmm-yyyy)

5. Describe Event, Problem or Product Use Error

6. Is the Product
Compounded?

#1

Required Intervention to Prevent Permanent Impairment/Damage (Devices)

26- Jun- 2015

No

8. Expiration Date (dd-mmm-yyyy)

Other Serious (Important Medical Events)

3. Date of Event (dd-mmm-yyyy)

Yes

10. Event Reappeared After
Reintroduction?

#2

1. Check all that apply

Death

#1

#2

American Indian or Alaskan Native

Hispanic/Latino

9. Event Abated After Use
Stopped or Dose Reduced?

3. Occupation

No

4. Also Reported to:
Manufacturer/
Compounder
User Facility
Distributor/Importer

Submission of a report does not constitute an admission that medical personnel or the product caused or contributed to the event.

ADVICE ABOUT VOLUNTARY REPORTING

Detailed instructions available at: http://www.fda.gov/medwatch/report/consumer/instruct.htm

-Fold Here-

Report adverse events, product problems or product
use errors with:
• Medications (drugs or biologics)
• Medical devices (including in-vitro diagnostics)
• Combination products (medication & medical devices)
• Human cells, tissues, and cellular and tissue-based
products
• Special nutritional products (dietary supplements,
medical foods, infant formulas)
• Cosmetics
• Food (including beverages and ingredients added
to foods)
Report product problems - quality, performance or
safety concerns such as:
• Suspected counterfeit product
• Suspected contamination
• Questionable stability
• Defective components
• Poor packaging or labeling
• Therapeutic failures (product didn't work)
Report SERIOUS adverse events. An event is serious
when the patient outcome is:
• Death
• Life-threatening
• Hospitalization - initial or prolonged
• Disability or permanent damage
• Congenital anomaly/birth defect
• Required intervention to prevent permanent
impairment or damage (devices)
• Other serious (important medical events)

Report even if:
• You're not certain the product caused the event
• You don't have all the details
How to report:
• Just fill in the sections that apply to your report
• Use section D for all products except medical devices
• Attach additional pages if needed
• Use a separate form for each patient
• Report either to FDA or the manufacturer (or both)
Other methods of reporting:
• 1-800-FDA-0178 - To FAX report
• 1-800-FDA-1088 - To report by phone
• www.fda.gov/medwatch/report.htm - To report online
If your report involves a serious adverse event with a
device and it occurred in a facility outside a doctor's office,
that facility may be legally required to report to FDA and/or
the manufacturer. Please notify the person in that facility
who would handle such reporting.

-Fold Here-

If your report involves a serious adverse event with a
vaccine, call 1-800-822-7967 to report.
Confidentiality: The patient's identity is held in strict
confidence by FDA and protected to the fullest extent of
the law. The reporter's identity, including the identity of a
self-reporter, may be shared with the manufacturer unless
requested otherwise.

PROOF

The information in this box applies only to requirements of the Paperwork Reduction Act of 1995
The burden time for this collection of information has been estimated to average 40 minutes per response, including the time to review
instructions, search existing data sources, gather and maintain the data needed, and complete and review 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
Please DO NOT
OMB statement:
Food and Drug Administration
RETURN this form
"An agency may not conduct or sponsor, and a
Office of Chief Information Officer
to the PRA Staff e-mail
person is not required to respond to, a collection of
Paperwork Reduction Act (PRA) Staff
to the left.
information unless it displays a currently valid
PRAStaff@fda.hhs.gov
OMB control number."
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

FORM FDA 3500 (5/15) (Back)

Please Use Address Provided Below -- Fold in Thirds, Tape and Mail

DEPARTMENT OF
HEALTH & HUMAN SERVICES

NO POSTAGE
NECESSARY
IF MAILED
IN THE
UNITED STATES
OR APO/FPO

Public Health Service
Food and Drug Administration
Rockville, MD 20857
Official Business
Penalty for Private Use $300

BUSINESS REPLY MAIL
FIRST CLASS MAIL PERMIT NO. 946 ROCKVILLE MD

POSTAGE WILL BE PAID BY FOOD AND DRUG ADMINISTRATION

MEDWATCH

The FDA Safety Information and Adverse Event Reporting Program
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852-9787

U.S. Department of Health and Human Services

MEDWATCH

The FDA Safety Information and
Adverse Event Reporting Program

(CONTINUATION PAGE)

For VOLUNTARY reporting of
adverse events and product problems

FORM FDA 3500 (5/15) (continued)

Page 3 of

B.5. Describe Event or Problem (continued)

Designer note: The action buttons on pages 2 and 3 temporarily dropped out of
the form when the functionally simpler "Acro" PDF file was generated for proof
purposes (to allow for combining pages 2 and 3 with the new page 1 PDF that was
designed in different software). Those buttons will continue to exist and work in the
final "Adobe LIveCycle" functional and 508-compliant PDF form that will be made
after FDA approves this revised layout.

B.6. Relevant Tests/Laboratory Data, Including Dates (continued)

PROOF

B.7. Other Relevant History, Including Preexisting Medical Conditions (e.g., allergies, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.) (continued)

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