Characterizing MAUDE Reports for Xenform Bovine Dermal Matrix in Transvaginal Pelvic Organ Prolapse Repair: A Mixed-Methods Descriptive Analysis.

Few MAUDE narratives contained sufficient detail to implicate Xenform in a device-attributed adverse event.

Report volume peaked in 2013 coincident with FDA regulatory activity and mesh litigation, suggesting Xenform reporting patterns may have reflected the broader medicolegal context rather than a material-specific safety signal.

The absence of detailed reporting is not evidence of safety; but reflects structural limitations of passive surveillance.