Indicator, Biological Sterilization Process

What the Data Shows About Indicator, Biological Sterilization Process

The FDA MAUDE database aggregates 1,469 adverse-event reports for Indicator, Biological Sterilization Process spanning the period from 1995 through 2025. Of these, 0 are classified as death reports, 24 as injury reports, and 1,346 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 4 distinct event types and 4 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 Appropriate Term/Code Not Available topping the list at 471 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 29 years of MAUDE data, with the peak single-year volume reaching 482 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 7 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.