Reports of anesthesia-related adverse events.
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.
Graham
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US FDA, Center for Devices and Radiological Health, Rockville, MD 20857, USA.
D000768:Anesthesia, General / Q000295:instrumentation*; D004868:Equipment Failure; D006801:Humans; D007231:Infant, Newborn; D007442:Intubation, Intratracheal / Q000295:instrumentation*; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration