BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 6016501 · Received October 11, 2016

    Report

    Report Number
    6016501
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    January 18, 2016
    Report Date
    September 23, 2016
    Manufacturer
    ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE DEPLOYING THE MYNX DEVICE, IT CAME OUT OF THE PATIENT'S LEG WHEN THE SHEATH WAS PULLED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667472 MYNX VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY F1531602

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR