CONCEAL

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404237. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100779063. MODEL/CATALOG DESCRIPTION: CX PRECONNECT MS 18CM IP IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THIS PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) SNEEZED AND WAS ADMITTED INTO THE HOSPITAL AS THE RESERVOIR HAD DISPLACED INTO THEIR GROIN. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE RESERVOIR WAS EXPLANTED AND REPLACED WITH A TRANSFACIAL FIXATION TECHNIQUE. NO ADDITIONAL INFORMATION WAS PROVIDED.