BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX ACE

    MDR report key: 4340455 · Received December 16, 2014

    Report

    Report Number
    4340455
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Date of Event
    July 28, 2014
    Report Date
    December 16, 2014
    Manufacturer
    ACCESSCLOSURE, INC. A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    MYNX DEVICE WAS ATTEMPTED TO BE DEPLOYED BUT WAS UNSUCCESSFUL. MANUAL PRESSURE WAS USED TO OBTAIN HEMOSTASIS WITH DSTAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823853 MYNX ACE DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC. A CARDINAL HEALTH COMPANY * F1413601

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR