AMS 700? CX TENACIO? Pump

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) DEVELOPED AN INFECTION IN THE SCROTAL AREA. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE IPP AND ALLOW THE PATIENT TIME TO HEAL, AND MEDICATION WAS PRESCRIBED. FOLLOWING RECOVERY, A NEW IPP WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404156. SERIAL NUMBER: N/A . BATCH/LOT NUMBER: 1100611588. MODEL/CATALOG DESCRIPTION: RESERVOIR 100 ML PC/IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. BASED ON THE AVAILABLE INFORMATION, THE CONCLUSION CODE OF ADVERSE EVENT RELATED TO PROCEDURE WAS ASSIGNED TO THIS INVESTIGATION, AS THE INFECTION WAS MOST LIKELY ATTRIBUTED TO THE SURGICAL PROCEDURE. INFECTION IS IDENTIFIED IN THE INSTRUCTIONS FOR USE (IFU) AS A KNOWN SURGICAL RISK AND POTENTIAL ADVERSE EVENT.