N/A

Description of Event or Problem

IT WAS REPORTED THAT THE DEVICE WOULD NOT HOLD PRESSURE. NO PATIENT INJURY WAS REPORTED.

Additional Manufacturer Narrative

THIS MDR IS ASSOCIATED WITH AN ASCENT VOLUNTARY RECALL FOR SIX (6) FEMOSTOP LOT NUMBERS WHERE THE DEVICE MAY FAIL TO INFLATE PROPERLY AND MAY LEAK DUE TO A SEAL SEPARATION BETWEEN THE DOME AND PLASTIC ARCH BASE. INITIALLY THIS WAS NOT CONSIDERED A MDR REPORTABLE EVENT BECAUSE THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION WAS NOT REQUIRED, AND ASCENT HAD NO HISTORY OF ANY PATIENT INJURY DUE TO THIS TYPE OF MALFUNCTION. ON JUNE 18TH ASCENT INITIATED A VOLUNTARY RECALL FOR THE SIX FEMOSTOP LOT NUMBERS SO THIS MDR IS BEING FILED DUE TO THE RECALL. THE PATIENT INFORMATION WAS NOT PROVIDED TO ASCENT.