BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX DEVICE ANGIOSEAL

    MDR report key: 8964854 · Received September 4, 2019

    Report

    Report Number
    MW5089549
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 26, 2019
    Report Date
    August 30, 2019
    Manufacturer
    CARDINAL HEALTH CO. / ACCESSCLOSURE, INC.
    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 DEVICE WAS PLACED AFTER WHICH THE BALLOON RUPTURED. MANUAL PRESSURE WAS HELD AFTER PROCEDURE. NO COMPLICATIONS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757291 MYNX DEVICE ANGIOSEAL DEVICE, HEMOSTASIS, VASCULAR MGB CARDINAL HEALTH CO. / ACCESSCLOSURE, INC. F1916501

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR