CONCEAL

Additional Manufacturer Narrative

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. THE REPORTED PATIENT SYMPTOM IS A KNOWN RISK ASSOCIATED WITH THIS DEVICE TYPE AND INDICATED AS SUCH IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

Description of Event or Problem

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