BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX

    MDR report key: 2548612 · Received April 13, 2012

    Report

    Report Number
    2548612
    Event Type
    Malfunction
    Date Received
    April 13, 2012
    Date of Event
    February 20, 2012
    Report Date
    April 13, 2012
    Manufacturer
    ACCESS CLOSURE, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR WAS DEPLOYING THE MYNX SYSTEM WHEN THE BALLOON RUPUTED ON THE DEVICE AND CAUSE A FAILURE IN DEPLOYMENT. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX DEVICE, HEMOSTASIS, VASCULAR MGB ACCESS CLOSURE, INC. MX5000 F1106602

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR