BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE

    MDR report key: 2933597 · Received January 25, 2013

    Report

    Report Number
    2933597
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE FAILED WHEN INSERTED. BALLOON WOULD NOT INFLATE APPROPRIATELY. DEVICE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36300 MYNXGRIP VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB ACCESSCLOSURE, INC. * F1232001

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR