FDA 483 - CM Technologies, Inc - February 10, 2025

CM Technologies, Inc. in Carrollton, TX, an initial importer, was cited by the FDA for failing to submit Medical Device Reports (MDRs) for serious injuries. The firm did not report multiple instances of severe rectal bleeding and other serious patient outcomes associated with its marketed fecal management system. This indicates a significant lapse in post-market surveillance and reporting requirements.