BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP

    MDR report key: 4449922 · Received January 9, 2015

    Report

    Report Number
    4449922
    Event Type
    Malfunction
    Date Received
    January 9, 2015
    Date of Event
    December 5, 2014
    Report Date
    January 9, 2015
    Manufacturer
    ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    MYNX DEFECTIVE - IT DISCONNECTED IN THE MIDDLE. IT DID NOT WORK AND IT WAS REMOVED FROM PATIENT AND REPLACED BY ANOTHER MYNX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23820 MYNXGRIP DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY MX5021 F1406603

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR