A new analysis of the FDA’s Manufacturer and User Facility Device Experience database finds patient deaths associated with the use of medical devices are being mislabeled in the system and potentially being missed by the agency.
In a manual review of 1,000 adverse event medical device reports identified by a natural language processing algorithm, used to identify mislabeled patient death reports in the MAUDE system, 23% of reports were labeled as injury, malfunction, missing or other, rather than death, according to the study published Monday in JAMA Internal Medicine.
The report raises more questions about the FDA’s complex and often opaque public reporting process and database for medical device adverse event reports.
Read the full article on MedTechDive.