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MAUDE data represents reports of adverse events involving medical devices. Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to ...
Maude: Created by Norman Lear. With Bea Arthur, Bill Macy, Conrad Bain, Adrienne Barbeau. "All In The Family" spin-off centered around Edith's cousin, Maude Findlay, a liberal, independent woman living in Tuckahoe, New York.
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MAUDE Adverse Event Report: MRI MACHINE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING. My (b) (6) year old son's teeth, hands, lips, legs were burned during an mri.Neck muscles were damaged.My husband and i drove my son from (b) (6) to see a licenced physician who examined my son and provided me with letters recommending that my son is no longer ...
Apr 5, 2024 · Introduction Pancreatic duct stents (PDS) are widely used for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, there is a paucity of data regarding the adverse events associated with PDS placement. This study aims to investigate the reported adverse events and device failures related to PDS, utilizing the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the U.S. Food and Drug Administration (FDA). Methods Post ...
6 days ago · The Manufacturer and User Facility Device Experience (MAUDE) database is a searchable database of medical device reports (MDRs) of adverse events involving medical devices over the last ten years. Reports older than ten years are provided on the FDA's MDR Data Files webpage. Is updated every month to include reports received through the last ...
May 1, 2020 · Abstract. This article provides recommendations to manufacturers on using the Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) and Medical Device Recall databases to identify unknown use issues, discover design opportunities, and improve one's risk management file. These recommendations are based on the experiences of researchers who have spent time analyzing and working with both database systems and have developed a methodology for each. Manufacturers ...
The Manufacturer and User Facility Device Experience (MAUDE) database is a searchable database of medical device reports (MDRs) of adverse events involving medical devices over the last ten years. Reports older than ten years are provided on the FDA's MDR Data Files webpage. The MAUDE database: Is updated every month to include reports received ...
