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Consumers play an important public health role by reporting to the Food and Drug Administration (FDA) any adverse events (unexpected side effects) after using a medical product, or other problems with any products that the agency regulates. Timely reporting allows the agency to take prompt action. There are a number of ways you can report problems to the agency, depending on the type of problem and product. The following tips and chart will help you make your report.
1. Report what happened as soon as possible after you discover a problem. Be prepared with the following information:
2. Do not discard the product packaging and labeling. They provide codes, numbers, and dates that will help FDA trace the product back to the plant.
3. In addition to reporting to FDA, the agency recommends reporting the problem to the manufacturer and to the store where the product was purchased.
4. When in doubt about how to report a problem, call your local FDA Consumer Complaint Coordinator listed at www.fda.gov/opacom/backgrounders/complain.html.
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human health care products:
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Contact the agencies listed to report or complain about the following problem areas. See your local phone directory for phone numbers not provided here.
This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest on all FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.
Protect Your Health
Joint FDA/WebMD resource
www.webmd.com/fda
FDA 101: How to Use the Consumer Complaint System and MedWatch
www.fda.gov/consumer/updates/reporting061008.html
Updated: March 3, 2009