Why should I report?

The testing that helps to establish the safety of products,… Why should I report?

The testing that helps to establish the safety of products, such as drugs and medical devices, is typically conducted on small groups before FDA approves the products for sale. Some problems can remain unknown, only to be discovered when a product is used by a large number of people.

When problems with FDA-regulated products occur, the agency wants to know about them and has several ways for the public to make reports. Timely reporting by consumers, health professionals and FDA-regulated companies allows the agency to take prompt action. The agency evaluates each report to determine how serious the problem is, and, if necessary, may request additional information from the person who filed the report before taking action.

What should I include in my report?

Report what happened as soon as possible. Give names, addresses and phone numbers of persons affected. Include your name, address and phone number, as well as that of the doctor or hospital if emergency treatment was provided.

* State the problem clearly. Describe the product as completely as possible, including any codes or identifying marks on the label or container. Give the name and address of the store where the product was purchased and the date of purchase.

* You also should report the problem to the manufacturer or distributor shown on the label and to the store where you purchased the product.

To report adverse reactions or other problems with FDA-regulated products, contact the FDA district office consumer complaint coordinator for your geographic area. If you require the use of a Relay Service, please call the Federal Relay Services (1-800-877-8339). This is a toll-free relay service to call federal agencies from TTY devices.

Pennsylvania — (215) 597-9064