BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR, W/LOCK OUT CLOVERLEAF 75CC

    MDR report key: 3871132 · Received May 29, 2014

    Report

    Report Number
    3871132
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    March 13, 2014
    Report Date
    May 29, 2014
    Manufacturer
    COLOPLAST CORP.
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    FAILED PENILE IMPLANT. WITH THE PUMP OUT, IT COULD BE SEEN THAT ONE OF THE WELDS FROM THE CYLINDER TUBING TO THE PUMP HAD FRAYED AND WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317212 RESERVOIR, W/LOCK OUT CLOVERLEAF 75CC DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW COLOPLAST CORP. * 2734258
    317213 TITAN DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW COLOPLAST CORP. * 1942014
    317214 KIT, ASSEMBLY W/MEASUREMENTS TITAN PENILE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW COLOPLAST CORP. * 1942014

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR