Adverse event

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An adverse event (AE) is any change in health that occurs in a person after he or she enrolls in a clinical trial. Not every adverse event is related to the treatment or test being studied, but researchers must report all adverse events to the Food and Drug Administration (FDA).

An adverse event can also be declared in the normal treatment of a patient which is suspected of being caused by a medical device used in the treatment of the patient. The FDA provides a database for reporting of adverse events call the Manufacturer and User Facility Device Experience Database. (MAUDE)[1] The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996 and is open for public view.