BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP

    MDR report key: 2945491 · Received January 22, 2013

    Report

    Report Number
    2945491
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    October 19, 2012
    Report Date
    January 22, 2013
    Manufacturer
    ACCESS CLOSURE, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE UNABLE TO DEPLOY; DEVICE REMOVED AND MANUAL PRESSURE APPLIED.======================MANUFACTURER RESPONSE FOR MYNX CLOSURE DEVICE, MYNX GRIP ACCESS CLOSURE DEVICE (PER SITE REPORTER).======================REPLACED ITEM WITH SAME TYPE OF ITEM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CARDIAC CATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29999 MYNXGRIP DEVICE, HEMOSTASIS, VASCULAR MGB ACCESS CLOSURE, INC. * F1219201

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR CARDIAC DRUGS