BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV3 NITREX GUIDEWIRES

    MDR report key: 960729 · Received December 5, 2007

    Report

    Report Number
    MW5004604
    Event Type
    Malfunction
    Date Received
    December 5, 2007
    Date of Event
    December 3, 2005
    Report Date
    December 5, 2007
    Manufacturer
    EV3INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP OF GUIDEWIRE BROKE OFF IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EV3 NITREX GUIDEWIRES GUIDEWIRES DQX EV3INC. NITREX 01986986

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other