CONCEAL

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404251. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100788729. MODEL/CATALOG DESCRIPTION: LGX PRECONNECT MS 15CM PS IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) EXPERIENCED RIGHT INGUINAL PAIN. THE RESERVOIR WAS FOUND TO HAVE MIGRATED TO THE RIGHT INGUINAL REGION. A SURGICAL PROCEDURE WAS PERFORMED TO REMOVE AND REPLACE THE RESERVOIR. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.