BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP

    MDR report key: 4945305 · Received July 24, 2015

    Report

    Report Number
    4945305
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 24, 2015
    Manufacturer
    ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    THE VASCULAR CLOSURE DEVICE FAILED CAUSING MANUAL PRESSURE TO BE APPLIED TO SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483373 MYNXGRIP DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY * F1514001

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR