BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX

    MDR report key: 2894157 · Received December 26, 2012

    Report

    Report Number
    2894157
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    December 19, 2012
    Report Date
    December 26, 2012
    Manufacturer
    ACCESS CLOSURE, INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FEMALE PATIENT HAD CARDIAC CATHETERIZATION AND A MYNX CLOSURE DEVICE WAS USE TO CLOSE THE PUNCTURED ARTERY. SOMETIME AFTER THE PROCEDURE, PATIENT DEVELOPED RIGHT GROIN AND BACK PAIN AND A CT SCAN SHOWED A RETROPERITONEAL BLEED. PATIENT WAS TAKEN TO SURGERY AND IT IS BELIEVED THE MYNX CLOSURE DEVICE HAD MIGRATED ALLOWING BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX DEVICE, HEMOSTASIS, VASCULAR MGB ACCESS CLOSURE, INC. * F1221204

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R CARDIAC DRUGS