BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2476307 · Received February 13, 2012

    Report

    Report Number
    2476307
    Event Type
    Malfunction
    Date Received
    February 13, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 13, 2012
    Manufacturer
    COLOPLAST CORP.
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT STATES THAT HIS ARTIFICIAL URINARY SPHINCTER STOPPED WORKING TWO WEEKS AGO. IT WILL NOT INFLATE OR DO ANYTHING. THE MFR REP IS PICKING DEVICE UP TOMORROW MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ALPHA SCROTAL CYLINDER SET WITH PUMP FHW COLOPLAST CORP. * *
    2 * BIOFLEX RESERVOIR LOCKOUT VALVE FHW COLOPLAST CORP * *
    3 * TITAN ASSEMBLY KIT FHW COLOPLAST CORP * 798404

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR