BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNADO

    MDR report key: 2843549 · Received November 19, 2012

    Report

    Report Number
    2843549
    Event Type
    Malfunction
    Date Received
    November 19, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 19, 2012
    Manufacturer
    COOK, INC.
    Product Code
    KRD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COIL MALPOSITIONED. COIL WAS SNARED AND STRETCHED/FRACTURED. PART OF THE COIL WAS LEFT IN ITS POSITION. COIL SEEMS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNADO EMBOLIZATION COIL KRD COOK, INC. * 2516032

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR