CONCEAL

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404231. SERIAL NUMBER: N/A BATCH/LOT NUMBER: 1100908460 MODEL/CATALOG DESCRIPTION: CX RECONNECT MS 15CM PS IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) DEVELOPED A POSTOPERATIVE HEMATOMA AND EXPERIENCED SCROTAL PAIN. AS A RESULT, THE PHYSICIAN DRAINED THE HEMATOMA AND CREATED A COUNTER INCISION FOR RESERVOIR PLACEMENT, AS IT WAS BEGINNING TO MIGRATE THROUGH THE INGUINAL RING. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.