BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX

    MDR report key: 2931597 · Received January 22, 2013

    Report

    Report Number
    2931597
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ACCESSCLOSURE
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CLOSURE DEVICE FAILED UPON DEPLOYMENT. THE DEVICE HAD TO BE REMOVED AND ANOTHER DEVICE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30945 MYNX DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE * F1221508

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR