Report A Problem With A Medical Product printable pdf download

MEDWATCH CONSUMER REPORTING FORM 3500

Report a Problem With a Medical Product

When do I use this form?

What types of products should I use this form for?

You were hurt or had a bad side effect (including new

Drugs, including prescription or over-the-counter

•

or worsening symptoms) after taking a drug or using

medications

a medical device or product.

Medical devices, including any health-related kit,

•

You used a drug, product, or medical device

test, tool, or piece of equipment (such as breast

•

incorrectly which could have or led to unsafe use.

implants, pacemakers, diabetes glucose-test kits,

hearing aids, breast pumps, and many others)

You noticed a problem with the quality of the drug,

•

product or medical device.

Nutrition products including vitamins and minerals,

•

herbal remedies, infant formulas, medical foods,

You had problems with how a drug worked after

•

such as those labeled for people with a specific

switching from one maker to another maker.

disease or condition

Don’t use this form to report:

Tobacco and nicotine products, including those to

•

Vaccines – report problems to the Vaccine Adverse

•

help you quit

Event Reporting System (VAERS)

Cosmetics or make-up products

•

Investigational drugs or medical devices (those

•

Are there specific instructions for filling out

being studied, not yet approved) – report problems

the form?

to your doctor or to the contact person listed in the

Fill in as much information as possible and submit

•

clinical trial

the report even if you do not have all the information

Food – report problems to your local county

•

requested.

department of health

You can fill out this form yourself or have someone fill

•

Will the information I report be kept private?

it out for you. If you need help, you may want talk with

The FDA recognizes that privacy is an important concern,

your health professional.

so you should know:

Feel free to include or attach an image. Please do not

•

We ask only for the name and contact information of

•

send the products to the FDA.

the person filling out the form so that we may contact

How will I know the FDA has received my form?

them if we need more information. Your name will not

be given out to the public. This information may be

You will receive a reply from the FDA after we receive your

shared with the company that makes the product to

report. We will personally contact you only if we need

additional information.

help them evaluate the problem you are reporting,

unless you request otherwise (see Section E).

Who can I call if I have questions?

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

Please DO NOT

OMB statement:

Food and Drug Administration

RETURN this form

“An agency may not conduct or

Office of Chief Information Officer

to this address.

sponsor, and a person is not required to

1350 Piccard Drive, Room 400

respond to, a collection of information

Rockville, MD 20850

unless it displays a currently valid OMB

control number.”

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Report A Problem With A Medical Product

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