BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1653570 · Received April 2, 2010

    Report

    Report Number
    MW5015450
    Event Type
    Malfunction
    Date Received
    April 2, 2010
    Date of Event
    March 24, 2010
    Report Date
    April 2, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MYNX VASCULAR CLOSURE DEVICE DEPLOYED LOT F0935202 2010-12-31 LEFT FEMORAL ARTERY. INITIALLY UNABLE TO REMOVE THE WIRE AND BALLOON POST MYNX DEPLOYMENT. EVENTUALLY BALLOON AND WIRE WERE PULLED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MYNX VASCULAR CLOSURE DEVICE MGB ACCESSCLOSURE, INC. F0935202

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR