CONCEAL

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404233-12. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100840757. MODEL/CATALOG DESCRIPTION: CX PRECONNECT MS 21CM PS 12CM TL IZ UPN. 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 SCROTAL AREA. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE RESERVOIR HAD MIGRATED FROM ITS ORIGINAL POSITION AND WAS NOT PROPERLY SECURED. THE RESERVOIR WAS EXPLANTED AND REPLACED IN A NEW LOCATION. THERE WERE NO PATIENT COMPLICATIONS.