BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP

    MDR report key: 5090438 · Received September 21, 2015

    Report

    Report Number
    5090438
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 11, 2015
    Manufacturer
    ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA.

    Description of Event or Problem · 1

    THE MYNX CLOSURE DEVICE MALFUNCTIONED DURING DEPLOYMENT. MANUAL PRESSURE WAS HELD TO THE RIGHT FEMORAL ARTERY SITE BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623084 MYNXGRIP DEVICE, HEMOSTASIS VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY F1515405

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR