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  1. www.accessdata.fda.gov › cfMAUDE › resultsManufacturer and User Facility Device Experience (MAUDE) Database

    31 de mai. de 2024 · 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...

  2. www.fda.gov › news-events › press-announcementsFDA Roundup: June 7, 2024 | FDA - U.S. Food and Drug ...

    7 de jun. de 2024 · On Thursday, the FDA updated the Manufacturer and User Facility Device Experience (MAUDE) database, which contains medical device reports (MDRs) of adverse events, to provide additional...

  3. link.springer.com › article › 10A Comprehensive Analysis of Reported Adverse Events and ...

    29 de mai. de 2024 · The aim of this study is to investigate the reported adverse events and device failures associated with esophageal self-expandable metal stents (SEMS) using the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.

  4. thejns.org › abstract › journalsCharacterizing the safety profile of vagus nerve stimulation ...

    14 de jun. de 2024 · This study summarizes medical device reports (MDRs) associated with adverse events for vagus nerve stimulation (VNS) devices indicated for epilepsy as reported by the Manufacturer and User Facility Device Experience (MAUDE) database of the US Food and Drug Administration.

  5. www.fda.gov › safety › medwatch-fda-safetyReporting Serious Problems to FDA | FDA - U.S. Food and Drug ...

    10 de jun. de 2024 · MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human...

  6. www.datacreds.com › post › how-medical-device-safetyHow Medical Device Safety Databases Improve Productivity

    3 de jun. de 2024 · Real-world examples, including the FDA's MAUDE database and the EU's EUDAMED, demonstrate the significant benefits of safety databases in improving productivity and ensuring device safety.

  7. www.tandfonline.com › doi › fullFull article: A comparative study of medical device ...

    4 de jun. de 2024 · The study sheds light on 31 fatal and 1353 nonfatal instances related to these devices using data from the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the US FDA between 1 January 1997, and 30 June 2002.