BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION QUATTRO

    MDR report key: 3861320 · Received May 28, 2014

    Report

    Report Number
    3861320
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    October 22, 2013
    Report Date
    April 30, 2014
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    GCA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314708 FUSION QUATTRO CATHETER, BILIARY, SURGICAL GCA WILSON-COOK MEDICAL INC. * W3333045

    Patients

    Seq Age Sex Outcome Treatment
    1 *