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Reports of anesthesia-related adverse events
1US FDA, Center for Devices and Radiological Health, Rockville, MD 20857, USA.
International Journal of Trauma Nursing
|December 18, 1998
Abstract:
A case report involving an anesthesia adverse event that was received in the FDA database was used to demonstrate postmarket reporting of medical devices by the manufacturers and the FDA. Even common, everyday adverse events are evaluated and used to improve the safety and efficacy of medical products. Instructions for accessing the FDA MedWatch forms and coding manual are provided, and readers are referred to additional resources on the FDA website.