Report A Problem With A Medical Product (Page 4 of 4) in pdf

Report A Problem With A Medical Product Page 4

Section D – About the Person Who Had the Problem

Person’s

Sex

Age (at time the

Weight

Race

Initials

problem occurred)

(lbs or kg)



Female

or Birth Date



Male

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

Was 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.

Last name:

First name:

Number/Street:

City/State:

Zip Code:

Telephone:

Email:

Today’s Date:

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:

Fax:

MedWatch

800-332-0178 (toll-free)

Food and Drug Administration

For more information:

5600 Fishers Lane

Visit us at

Rockville, MD 20852

Call us at 800-332-1088 (toll-free)

Thank you for helping us protect the public health.

For more information visit

MedWatch Consumer Reporting Form Page 3 of 3

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

Report A Problem With A Medical Product Page 4

Related Articles

Related forms

Related Categories