BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX

    MDR report key: 6338782 · Received February 17, 2017

    Report

    Report Number
    6338782
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    January 25, 2017
    Report Date
    February 8, 2017
    Manufacturer
    ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER THE DEVICE DEPLOYED, BLEEDING PERSISTED WITH A SMALL HEMATOMA IN RIGHT GROIN. PRESSURE WAS HELD AT THE SITE FOR 20 MIN AND THE HEMATOMA REDUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122041 MYNX DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY F1632803

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR