BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP

    MDR report key: 2770837 · Received September 10, 2012

    Report

    Report Number
    2770837
    Event Type
    Malfunction
    Date Received
    September 10, 2012
    Date of Event
    August 29, 2012
    Report Date
    September 10, 2012
    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

    THE BALLOON FAILED UPON DEVICE PLACEMENT.======================MANUFACTURER RESPONSE FOR MYNX GRIP CLOSURE DEVICE, MYNX GRIP (PER SITE REPORTER).======================REPLACED FAULTY EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNXGRIP DEVICE, HEMOSTASIS, VASCULAR MGB ACCESS CLOSURE, INC. MX6721 F1219809

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR