BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 2406318 · Received January 4, 2012

    Report

    Report Number
    MW5023734
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Date of Event
    November 18, 2011
    Report Date
    November 18, 2011
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BENTSON GUIDEWIRE USED BY DR. (B)(6). WHILE PULLING OUT GUIDEWIRE PRODUCT FRAYED. PT NOT HARMED. (B)(6) EXAMINED PRODUCT AFTER REMOVAL AND ALL PARTS INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC BENTSON GUIDEWIRE DQX LAKE REGION MEDICAL 1004509

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR