Otologic use of porcine small intestinal submucosal graft (biodesign): A MAUDE database review.

Abstract

To review and summarize reported adverse events related to the use of porcine small intestine submucosal grafts (Biodesign™) in otologic procedures. Retrospective cross-sectional analysis. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database was queried for all medical device reports (MDR) related to otologic use of Biodesign™ (Cook Medical, Bloomington, IN) from January 2016 to November 2022. Adverse events (AEs) were identified by