CONCEAL

Additional Manufacturer Narrative

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. BASED ON THE INFORMATION AVAILABLE THE CAUSE THAT CONTRIBUTED TO THE REPORTED EVENT CANNOT BE ESTABLISHED. THEREFORE, A CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS ASSIGNED TO THIS INVESTIGATION. MODEL NUMBER/CATALOG NUMBER: 72404234-14 SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100745855 MODEL/CATALOG DESCRIPTION: CYLINDER AND PUMP UNIQUE IDENTIFIER (UDI) #(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED HEMATURIA AND THE RESERVOIR MIGRATED TO THE BLADDER. AS A RESULT, THE DEVICE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.