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Reporting of death in US Food and Drug Administration medical device adverse event reports in categories other than death.
August 11, 2021
Lalani C, Kunwar EM, Kinard M, et al. JAMA Intern Med. 2021;181(9):1217-1223.
Medical device-associated errors are common and often result in preventable patient harm. Based on medical device adverse event data reported to the FDA's Manufacturer and User Facility Device Experience (MAUDE), this study used natural language processing to identify events not classified as deaths even though the patient died. Findings suggest that approximately 17% of medical device events that resulted in death were classified in other categories.
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