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Report Adverse Events to the FDA

Consumers should report serious adverse events related to human medical products to the U.S. Food & Drug Administration (FDA).

In addition, sometimes these reports are and can be made by an injured consumers legal counsel, i.e. their attorney or lawyer that is investigating the merits of a product liability lawsuit on behalf of the injured individual.

Steps to Filing a Report with the FDA

The FDA has made reporting unsafe human medical products products very simple. You can use the online forms at the FDA website to report a serious adverse event.

Link to FDA Form:

You can also report unsafe human medical products by phone 1-800-216-7331 or letter (Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857).

FDA MedWatch Video: Reporting Adverse Events

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