BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 12662980 · Received October 20, 2021

    Report

    Report Number
    2125050-2021-01521
    Event Type
    Injury
    Date Received
    October 20, 2021
    Report Date
    April 8, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    PMA / PMN Number
    P000006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL EXAMINATION OF THE RETURNED CYLINDER REVEALED NO ABNORMALITIES THAT WOULD HAVE CONTRIBUTED TO THE REPORT OF EROSION. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT. H6 CODES UPDATED FROM A040503 MATERIAL EROSION & E2403 NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS TO A26 INSUFFICIENT INFORMATION & E2006 EROSION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 3/5/2024 INDICATES THE FOLLOWING: CHANGED DUE TO PREVIOUS DISTAL PERFORATION WITH PERFORATION SIDE CYLINDER BEING REMOVED TO ALLOW HEALING OF TISSUE BEFORE REPLACING.

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST, THOUGH NOT VERIFIED, MALFUNCTION. A TRUE LOCK WAS USED. THE PATIENT HAD AN IMPENDING EROSION, THEREFORE THE SURGEON DECIDED TO REMOVE ONE CYLINDER AND USE A TRU LOCK PLUG TO SECURE THE TUBING OF THE CYLINDER THAT WAS REMOVED. THE OTHER CYLINDER, PUMP AND RESERVOIR REMAIN IN SITU. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565208 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S ES29221022 6203713_ES29221022

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention