AMS 700? CX TENACIO? PUMP

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 720185-01, SERIAL NUMBER: N/A, BATCH/LOT NUMBER: 1100833800, MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML, UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EQUIPPED WITH A TENACIO PUMP STATED THAT HE EXPERIENCED PAIN AT THE PUMP SITE. ADDITIONALLY, THE PATIENT REPORTED THAT HE WAS UNABLE TO USE THE PUMP BECAUSE IT WAS TOO HARD. THE PATIENT STATED THAT HIS UROLOGIST WAS ABLE TO PARTIALLY INFLATE THE DEVICE; HOWEVER, DOING SO CAUSED SIGNIFICANT PAIN. A REVISION PROCEDURE WAS SCHEDULED; HOWEVER, THE PATIENT DEVELOPED A URINARY TRACT INFECTION (UTI) THAT REQUIRED HOSPITALIZATION. A FOLLOW-UP APPOINTMENT HAS BEEN SCHEDULED AFTER THE UTI TO ENSURE EVERYTHING HAS RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.