CONCEAL

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED EROSION DIAGNOSED AS THE BULGE FROM THE RESERVOIR WAS VISIBLE THROUGH THE SKIN AND ALSO DISCOMFORT AT THE SITE OF THE RESERVOIR WAS NOTED AS IT MIGRATED FROM THE SPACE OF RETZIUS TO THE PATIENT'S PELVIS. A SURGICAL PROCEDURE WAS PERFORMED, AND THE RESERVOIR WAS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS.

Additional Manufacturer Narrative

THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOM(S) ARE KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, THE CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION. MODEL NUMBER/CATALOG NUMBER: 720185-01. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100683204. MODEL/CATALOG DESCRIPTION: RESERVOIR FLAT IZ 100 ML. UNIQUE IDENTIFIER (UDI) #: ((B)(4).