Device, Incontinence, Urosheath Type, Non-Sterile

What the Data Shows About Device, Incontinence, Urosheath Type, Non-Sterile

The FDA MAUDE database aggregates 909 adverse-event reports for Device, Incontinence, Urosheath Type, Non-Sterile spanning the period from 2012 through 2025. Of these, 0 are classified as death reports, 169 as injury reports, and 740 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 2 distinct event types and 7 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Nonstandard Device topping the list at 526 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 13 years of MAUDE data, with the peak single-year volume reaching 180 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 6 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on 2026-05-15. This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.