Adverse event

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An adverse event (AE) is any adverse change in health or "side-effect" that occurs in a person during a clinical trial or within a pre-specified period after dosing is complete. Not every adverse event is causally related to the treatment or test being studied, but researchers must report all adverse events to the Food and Drug Administration (FDA)or the relevant regulatory authority in the country where the drug or device is to be registered. Adverse events categorized as "serious" [for example death, illness requiring hospitalization, events deemed life-threatening, or involving cancer or fetal exposure] must be reported to the regulatory authorities immediately, whereas minor adverse events are merely documented in the annual summary sent to the regulatory authority.

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.