BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE

    MDR report key: 6452863 · Received March 30, 2017

    Report

    Report Number
    MW5068840
    Event Type
    Injury
    Date Received
    March 30, 2017
    Date of Event
    March 16, 2017
    Report Date
    March 30, 2017
    Manufacturer
    ACCESSCLOSURE INC. A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD A LOWER EXTREMITY SFA INTERVENTION WITH RIGHT FEMORAL ARTERY ACCESS. MYNX CLOSURE DEVICE WAS USED AT THE COMPLETION OF THE PROCEDURE. PT DEVELOPED A RETROPERITONEAL BLEED POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230533 MYNXGRIP VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE INC. A CARDINAL HEALTH COMPANY F1703304

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization