BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CONTROL VASCULAR CLOSURE DEVICE

    MDR report key: 8955708 · Received August 30, 2019

    Report

    Report Number
    MW5089490
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    August 27, 2019
    Report Date
    August 29, 2019
    Manufacturer
    MYNX / ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MYNX CLOSURE DEVICE USED AND FAILED. DIRECT PRESSURE HELD. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746184 MYNX CONTROL VASCULAR CLOSURE DEVICE DEVICE HEMOSTASIS, VASCULAR MGB MYNX / ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY F1916501

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR