Form FDA 3500b FDA 3500b MedWatch Consumer Reporting

Form Approved: OMB No. xxxx-xxxx
Expiration Date: xx/xx/201x
(See Burden Statement below)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

MEDWATCH Consumer Reporting

MEDICAL PRODUCT PROBLEM REPORT
(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.

tissues used for transplantation (for example, tendons,
ligaments and bone) and gene therapies

• You used a drug, product, or medical device incorrectly
which could have or led to unsafe use.

• 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 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.

• Tobacco and nicotine products, including those to help
you quit

Don’t use this form to report:

• Cosmetics or make-up products

• Vaccines – report problems to the Vaccine Adverse
Event Reporting System (VAERS)

Are there specific instructions for filling out the
form?

• Investigational drugs or medical devices (those being
studied, not yet approved) – report problems to your
doctor or to the contact person listed in the clinical trial
• Food – report problems to your local department of
health

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Will the information I report be kept private?

The FDA recognizes that privacy is an important concern,
so you should know:

• Fill in as much information as possible and send in the
report even if you do not have all the information.
• You can fill out this form yourself or have someone fill
it out for you. If you need help, you may want talk with
your health professional.
• Feel free to include or attach an image. Please do not
send the products to the FDA.

• We ask only for the name and contact information of
the person filling out the form in case we need more
information. This information will not be given out to the
public.

How will I know the FDA has received my form?

• Information about the problem 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).

• 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.

What types of products should I use this form
for?

Who can I call if I have questions?

• Drugs, including prescription or over-the-counter
medicines, and biologics, such as human cells and

• You will receive a reply from the FDA after we receive
your report. We will personally contact you only if we
need additional information.

Call the FDA’s MedWatch toll-free line: 800-332-1088.

The public reporting burden for this collection of information has been estimated to average 36 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
Office of Chief Information Officer
1350 Piccard Drive, Room 400
Rockville, MD 20850
FORM FDA 3500B (12/11)

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.”

MedWatch – Medical Product Problem Report

General Information Page
PSC Publishing Services (301) 443-6740

EF

Form Approved: OMB No. xxxx-xxxx
Expiration Date: xx/xx/201x
(See Burden Statement on
preceding general information page)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

MEDWATCH Consumer Reporting

MEDICAL PRODUCT PROBLEM REPORT
(FORM FDA 3500B)

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)
Designer note: Entry fields will
Disability or health problem be added after this visual layout

Used a product incorrectly which could have or led to a
problem
Noticed a problem with the quality of the product

proof is approved by FDA. At
that time the form also will be
made “508 compliant.”

Birth defect

Had problems after switching from one product maker
to another maker

Life-threatening
Death (include date):

Other serious/important medical incident (please list below)

Date the problem occurred (mm/dd/yyyy)

Tell us what happened and how it happened. (Include as many details as possible)

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

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
• tobacco and nicotine products, including those to help you quit
• cosmetics or make-up products



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 (12/11)

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

MedWatch – Medical Product Problem Report

Page 1 of 3
PSC Publishing Services (301) 443-6740

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 the product
Lot number

Expiration date (mm/dd/yyyy)

NDC number

Quantity (For example, 2 pills
or 2 puffs, etc)

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

Frequency (For example,
twice daily or at bedtime)

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)

Date the person first started taking
or using the product (mm/dd/yyyy):
Date the person stopped taking or
using the product (mm/dd/yyyy):
Did the problem stop after the
person reduced the dose or stopped
taking or using the product?

Yes

No

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

No

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.)
Yes

Didn’t restart

 Go to Section D (Skip section C)

No

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Section C – About the Medical Device

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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

Yes

A health professional (Such as a doctor, nurse, or aide)

No

Someone else (Please explain who)

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

Date the implant was taken out (If relevant) (mm/dd/yyyy)

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

FORM FDA 3500B (12/11)

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

MedWatch – Medical Product Problem Report

Page 2 of 3

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

Sex

Female

Age (at time the problem
occurred) or Birth Date

Weight (specify
lbs or kg)

Race

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

Is the person allergic to anything? (Such as drugs, foods, pollen or others)
Do you know any other important information about the person? (Such as smoking, pregnancy, alcohol use, etc.)
List all current prescription medications and medical devices being used.
List all over-the-counter medications and any vitamins, minerals, and herbal remedies.

 Go to Section E
Section E – About the Person Filling Out This Form
We will contact you only if we need additional information. Your name will not be given out to the public.

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First name

Last name

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City and State

Number/Street

ZIP code

Email address

Telephone number

Today’s date (mm/dd/yyyy)

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

No

May we give your name and contact information to the company that makes the product (manufacturer) to
help them evaluate the product?
Yes
No

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:
Mail:
MedWatch
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852

Fax:
800-332-0178 (toll-free)

For more information:
Visit us at http://www.fda.gov/MedWatch
Call us at 800-332-1088 (toll-free)

Thank you for helping us protect the public health.
For more information visit http://www.fda.gov/MedWatch

FORM FDA 3500B (12/11)

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

MedWatch – Medical Product Problem Report

Page 3 of 3