CONCEAL

Additional Manufacturer Narrative

MODEL NUMBER/CATALOG NUMBER: 72404238. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100134645. MODEL/CATALOG DESCRIPTION: CX PRECONNECT MS 21CM IP IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4). B3: DATE IS UNKNOWN, SO ESTIMATED DATE WAS ENTERED.

Description of Event or Problem

IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) WAS NOT FULLY INFLATING. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE DEVICE WAS EXPLANTED AND REPLACED. UPON EXPLANT, THE PHYSICIAN NOTED THE RESERVOIR WAS ONLY PARTIALLY FILLED AND THERE WAS FLUID LEAKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.