Form FDA 3500B FDA 3500B MedWatch Consumer Reporting

Form Approved: OMB No. 0910-0291
Expiration Date: 6/30/2015
(See PRA Statement below)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

MEDWATCH Consumer Voluntary Reporting
(FORM FDA 3500B)

When do I use this form?
• You were hurt or had a bad side effect (including new
or worsening symptoms) after taking a drug or using a
medical device or product.

• Medical devices, including any health-related kit, test,
tool, or piece of equipment (such as breast implants,
pacemakers, diabetes glucose-test kits, hearing aids,
breast pumps, and many others)
• Nutrition products including vitamins and minerals,
herbal remedies, infant formulas, medical foods, such
as those labeled for people with a specific disease or
condition

• You used a drug, product, or medical device incorrectly
which could have or led to unsafe use.
• You noticed a problem with the quality of the drug,
product or medical device.
• You had problems with how a drug worked after
switching from one maker to another maker.

• Cosmetics such as moisturizers, makeup, shampoos
and conditioners, face and body washes, deodorants,
nail care products, hair dyes and relaxers, and tattoos

Don’t use this form to report:

• Foods (including beverages and ingredients added to
foods)

• Vaccines – report problems to the Vaccine Adverse
Event Reporting System (VAERS)
• Investigational drugs or medical devices (those being
studied) – report problems to your doctor or to the
contact person listed in the clinical trial

Are there specific instructions for filling out the
form?

Will the information I report be kept private?

• Fill in as much information as possible and send in the
report even if you do not have all the information.

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The FDA recognizes that privacy is an important concern,
so you should know:
• We ask only for the name and contact information of
the person filling out the form in case we need more
information.

• Your name and contact information may be shared
with the company that makes the product to help them
better understand the problem you are reporting,
unless you request otherwise (see Section E).

What types of products should I use this form
for?
• Drugs, including prescription or over-the-counter
medicines, and biologics, such as human cells and
tissues used for transplantation (for example, tendons,
ligaments and bone) and gene therapies

• You can fill out this form yourself or have someone fill it
out for you. If you need help, you may want to talk with
your health professional.
• Feel free to include or attach an image of the product.
Please do not send the products to the FDA.

How will I know the FDA has received my form?
• You will receive a reply from the FDA after we receive
your report. We will personally contact you only if we
need additional information.
• Your report will become part of a database so that it
can be reviewed and compared to other reports by an
FDA safety evaluator who will determine what steps to
take.

Who can I call if I have questions?
Toll-free line: 1-800-332-1088
www.fda.gov/reportinghelp
To report online: www.fda.gov/medwatch/report.htm

The information below applies only to requirements of the Paperwork Reduction Act of 1995.
The burden time for this collection of information is estimated to average 30
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 information collection, including suggestions for reducing this
burden to the address to the right:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

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 number.”

DO NOT SEND YOUR COMPLETED FORM
TO THIS PRA STAFF ADDRESS.

FORM FDA 3500B (5/15)

MedWatch – Consumer Voluntary Reporting

General Information Page
EF

Form Approved: OMB No. 0910-0291
Expiration Date: 6/30/2015
(See PRA Statement on preceding
general information page)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

MEDWATCH Consumer Voluntary Reporting
(FORM FDA 3500B)

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

Section A – About the Problem
What kind of problem was it? (Check all that apply)

Did any of the following happen? (Check all that apply)

Were hurt or had a bad side effect (including new or
worsening symptoms)

Hospitalization – admitted or stayed longer
Required help to prevent permanent harm (for medical devices
only)

Used a product incorrectly which could have or led to a
problem

Disability or health problem

Noticed a problem with the quality of the product

Birth defect

Had problems after switching from one product maker
to another maker

Life-threatening
Death (include date)(dd-mmm-yyyy): 2 1 - A u g - 2 0 1 5
Other serious/important medical incident (please describe below)

Date the problem occurred (dd-mmm-yyyy)

2 1 - Au g - 2 0 1 5
Tell us what happened and how it happened. (Include as many details as possible)
Designer note: This is a “layout design”
(no entry fields) update proof. Entry fields
will be placed or adjusted as needed on the
final “508 compliant” form version after FDA
approves this layout design proof.

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Buttons do not work on
this layout design proof.

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List any relevant tests or laboratory data if you know them. (Include dates)

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For a problem with a product, including
• prescription or over-the-counter medicine
• biologics, such as human cells and tissues used for transplantation
(for example, tendons, ligaments, and bone) and gene therapies
• nutrition products, such as vitamins and minerals, herbal remedies, infant
formulas, and medical foods
• cosmetics or make-up products
• foods (including beverages and ingredients added to foods)



Go to Section B

For a problem with a medical device, including
• any health-related test, tool, or piece of equipment
• health-related kits, such as glucose monitoring kits or blood pressure cuffs
• implants, such as breast implants, pacemakers, or catheters
• other consumer health products, such as contact lenses, hearing aids, and
breast pumps



Go to Section C
(Skip Section B)

For more information visit http://www.fda.gov/MedWatch

FORM FDA 3500B (5/15)

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

MedWatch – Consumer Voluntary Reporting

Page 1 of 3
EF

Section B – About the Products
Name of the product as it appears on the box, bottle, or package (Include as many names as you see)
Name of the company that makes (or compounds) the product
Is the Product Compounded? (Your health professional
may be able to help you identify whether the drug was
compounded.)
Expiration date (dd-mmm-yyyy)

-

Yes

No

Is the Product
Over-the-Counter?

Yes

No

NDC number

Lot number

-

Strength (for example,
250 mg per 500 ml or 1g)

Quantity (for example, 2 pills,
2 puffs, or 1 teaspoon, etc.)

Date the person first started taking
or using the product (dd-mmm-yyyy):

-

-

Date the person stopped taking or
using the product (dd-mmm-yyyy):

-

-

Did the problem stop after the
person reduced the dose or stopped
taking or using the product?

Yes

No

How was it taken or used (for example, by
mouth, injection, or on the skin)?

Why was the person using the product? (such as what condition was it
supposed to treat)

No

Did the problem return if the person started taking or using
the product again?
Yes

Frequency (for example,
twice daily or at bedtime)

Do you still have the product in case we need to evaluate it? (Do not
send the product to FDA. We will contact you directly if we need it.)

Didn’t restart

 Go to Section D (Skip section C)

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Yes

No

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Section C – About the Medical Device
Name of medical device
Name of the company that makes the medical device
Other identifying information (The model, catalog, lot, serial, or UDI number, and the expiration date, if you can locate them)

Was someone operating the
medical device when the
problem occurred?

If yes, who was using it?
The person who had the problem
A health professional (such as a doctor, nurse, or aide)

Yes

Someone else (Please explain who)

No

For implanted medical devices ONLY (such as pacemakers, breast implants, etc.)
Date the implant was put in (dd-mmm-yyyy)

-

Date the implant was taken out (If relevant) (dd-mmm-yyyy)

-

-

-

 Go to Section D
For more information visit http://www.fda.gov/MedWatch

FORM FDA 3500B (5/15)

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

MedWatch – Consumer Voluntary Reporting

Page 2 of 3

Section D – About the Person Who Had the Problem
Person’s Initials

Race/
Ethnicity

Sex
Female

Age (specify unit of time for age)
Year(s)

Date of Birth
Month(s) (dd-mmm-yyyy)

Male

Week(s)

Day(s)

Ethnicity (Choose only one)
Hispanic/Latino
Not Hispanic/Latino

-

Weight (specify lbs or kg)

-

lbs

kg

Race (Choose all that apply)
American Indian or Alaskan Native
Native Hawaiian or Other Pacific Islander

Asian
White

Black or African
American

List known medical conditions. (Such as diabetes, high blood pressure, cancer, heart disease, or others)

Please list all allergies (such as to drugs, foods, pollen or others)
List any other important information about the person (such as smoking, pregnancy, alcohol use, etc.)
List all current prescription medications and medical devices being used.

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List all over-the-counter medications and any vitamins, minerals, supplements, and herbal remedies being used.
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 Go to Section E

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Section E – About the Person Filling Out This Form
We will contact you only if we need additional information.
Last name

First name

Number/Street

City and State/Province

Country

ZIP or Postal code

Telephone number

Email address

Today’s date (dd-mmm-yyyy)

Did you report this problem to the company that makes the product (the manufacturer/compounder)?

Yes

No

If you do NOT want your identity disclosed to the manufacturer, place an ’X’ in this box:

Send This Report By Mail or Fax
Keep the product in case the FDA wants to contact you for more information. Please do not send products to the FDA.
Mail or fax the form to: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852; FAX:
800-332-0178 (toll-free).
Thank you for helping us protect the public health.
For more information visit http://www.fda.gov/MedWatch

FORM FDA 3500B (5/15)

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

MedWatch – Consumer Voluntary Reporting

Page 3 of 3

Continued Entries
CONTINUED ENTRY FOR: Tell us what happened and how it happened. (Include as many details as possible)

Back to Form

CONTINUED ENTRY FOR: List any relevant tests or laboratory data if you know them. (Include dates)

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Back to Form

CONTINUED ENTRY FOR: List all current prescription medications and medical devices being used.

Back to Form

CONTINUED ENTRY FOR: List all over-the-counter medications and any vitamins, minerals, and herbal remedies being used.

Back to Form

FORM FDA 3500B (5/15)

MedWatch – Consumer Voluntary Reporting

Continuation Page