FDA 483 - Pfm Medical Cpp SA - July 11, 2018

Pfm Medical Cpp SA, a medical device manufacturer in La Chaux-de-Fonds, Switzerland, was cited for significant deficiencies in its Medical Device Reporting (MDR) system. The firm failed to submit MDR reports for several serious adverse events involving device malfunctions and patient injuries. Additionally, its written MDR procedure was found to be inadequate, lacking a comprehensive system for identifying, evaluating, and reporting such events.