BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN

    MDR report key: 3896511 · Received May 29, 2014

    Report

    Report Number
    3896511
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    February 27, 2014
    Report Date
    May 29, 2014
    Manufacturer
    COLOPLAST MANUFACTURING US, LLC
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    EROSION/MIGRATION OF PENILE PROSTHESIS. THE DEVICE WAS A 16 CENTIMETER DEVICE WITH NO REAR-TIP EXTENDERS, WHICH WAS WHAT THE PREVIOUS OPERATIVE REPORT SAID. PALPATION PROXIMALLY REVEALED LOSS OF CONTAINMENT ON THE LEFT SIDE, BUT NO REAR-TIP EXTENDERS ON EITHER SIDE NOTED. TUBING WAS TRACED UP TO THE RESERVOIR AFTER DEFLATING IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317347 TITAN DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW COLOPLAST MANUFACTURING US, LLC 17CM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NOT APPLICABLE.