BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILVERHAWK

    MDR report key: 2462650 · Received February 9, 2012

    Report

    Report Number
    2462650
    Event Type
    Malfunction
    Date Received
    February 9, 2012
    Date of Event
    November 14, 2011
    Report Date
    December 6, 2011
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    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
    1 SILVERHAWK PERIPHERAL CATHETER MCW EV3 INC. * 7326002

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR