BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUGE

    MDR report key: 2770841 · Received September 7, 2012

    Report

    Report Number
    2770841
    Event Type
    Malfunction
    Date Received
    September 7, 2012
    Date of Event
    August 25, 2012
    Report Date
    September 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    NOTICED THAT THE TIP OF THE WIRE WAS BROKEN (BENT) BEFORE IT WAS EVEN TAKEN OUT OF THE PACKAGE. ANOTHER WIRE WAS USED NOT SURE IF IT WAS FROM THE SAME LOT, BUT IT WAS FINE AND WORKED AS IT SHOULD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUGE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC * 14654191

    Patients

    Seq Age Sex Outcome Treatment
    1 *