BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK LTD

    MDR report key: 1822134 · Received August 23, 2010

    Report

    Report Number
    1822134
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 23, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    WHILE USING OUTBACK DEVICE A BMW WIRE WAS CAUGHT ON TIP OF THE DEVICE AND WAS SHEARED OFF. TIP WAS RETRIEVED AND A NEW DEVICE WAS USED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTBACK LTD CATHETER DQY CORDIS CORPORATION OTB42120 15182885

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR