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Há 1 dia · The MAUDE database was accessed on August 22,2022 from the following website: MAUDE - Manufacturer and User Facility Device Experience (fda.gov) and queried for all MDRs containing “WavelinQ” that had been reported to the database up to August 22,2022.
Há 3 horas · The (MAUDE) is a database that houses medical device reports for suspected device-associated deaths, serious injuries, and malfunctions submitted to the US Food and Drug Administration (FDA). These medical device reports were submitted by mandatory reporters (manufacturers, importers, and device user facilities) or by voluntary reporters such as healthcare professionals, patients, and consumers.
Há 3 dias · Crowder et al.’s study , based on 83 self-reports to the FDA MAUDE database, investigated adverse events post-implantation of either a Bonebridge or Osia device. Of the reported adverse events (91 in total), 34 were associated with Osia devices.
Há 1 dia · Yes, there was actually a paper that just came out recently looking at the MAUDE, M-A-U-D-E. This is the self-reported complications to the FDA with these devices. The most common one was subcutaneous emphysema. That is a laceration or false passage through the membranous wall. The membranous wall is only a few cells thick. …
Há 5 dias · In the future, we also want to use existing data about adverse events (partially annotated with terms from IMDRF taxonomies, e.g. from the FDA’s Manufacturer and User Device Facility Experience database, MAUDE ) to allow for a more informed evaluation of “whether all hazards have been identified“, a classical point of risk management that cannot strictly be proved by a manufacturer, but ...
Há 1 dia · And although the FDA’s MAUDE (Manufacturer and User Facility Device Experience) division recorded a significant uptick in complications associated with robotic prostatectomy, physicians still gave it the stamp of standard of care. Prostate cancer “treatments” lead to health dangers.
Há 1 dia · New guidance to advance medical device safety, regulatory oversight, and innovation. On April 17, the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) issued its 2024 safety report. As an update to their 2018 Medical Device Safety Action Plan, the safety reports is aligned with CDRH's vision to protect public ...
