CONCEAL

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404267. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100526411. MODEL/CATALOG DESCRIPTION: CXR PRECONNECT MS 14CM IP IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. MIGRATION IS ACKNOWLEDGED WITHIN THE INSTRUCTIONS FOR USE (IFU) AND IS NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED WITH A BULGE IN THE LOWER ABDOMEN UNDER THE SKIN. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE RESERVOIR HAD MIGRATED FROM ITS ORIGINAL LOCATION IN THE SPACE OF RETZIUS. THE RESERVOIR WAS EXPLANTED AND REPLACED WITH A NEW RESERVOIR POSITIONED UNDER THE LEFT RECTUS MUSCLE. THERE WERE NO PATIENT COMPLICATIONS.