BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-DOC

    MDR report key: 4910095 · Received July 10, 2015

    Report

    Report Number
    9681424-2015-00004
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 12, 2015
    Report Date
    July 9, 2015
    Manufacturer
    LABORIE MEDICAL TECHNOLOGIES, INC.
    Product Code
    FEN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN THEY REMOVED ONE CAT875 URODYNAMIC CATHETER FROM THE PACKAGE, THEY NOTICED A PIECE OF INTERNAL WIRE WAS STICKING OUT THROUGH THE CATHETER WALL. THE CATHETER WAS NOT USED ON A PT AND WILL BE RETURNED TO LABORIE FOR INVESTIGATION. IF IT HAD BEEN USED ON A PT, THERE WAS POTENTIAL THAT THE WIRE COULD HAVE MADE A TEAR IN THE URINARY TRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448398 T-DOC URODYNAMIC PRESSURE CATHETER FEN LABORIE MEDICAL TECHNOLOGIES, INC. TDOC-7FSC 141136

    Patients

    Seq Age Sex Outcome Treatment
    1