CONCEAL

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404233-12. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100741143. MODEL/CATALOG DESCRIPTION: CX PRECONNECT MS 21CM PS 12CM TL 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. DEVICE MIGRATION IS ACKNOWLEDGED WITHIN THE DIRECTIONS FOR USE (DFU) AND IS NOT RELATED TO OFF-LABEL USE OR FAILURE TO FOLLOW INSTRUCTIONS. A RISK REVIEW WAS COMPLETED, AND MIGRATION IS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. THE REPORTED MIGRATION IS A 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.

Description of Event or Problem

IT WAS REPORTED THAT THE RESERVOIR OF AN INFLATABLE PENILE PROSTHESIS (IPP) HAD MIGRATED FROM THE RIGHT RETROPUBIC SPACE ADJACENT TO THE BLADDER TO OUTSIDE THE INGUINAL RING DURING INTERCOURSE. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE RESERVOIR. NO PATIENT COMPLICATIONS WERE REPORTED.