BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX GRIP

    MDR report key: 6198170 · Received December 22, 2016

    Report

    Report Number
    6198170
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 23, 2016
    Report Date
    December 5, 2016
    Manufacturer
    ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BLACK TIP FRACTURED INSIDE OF PATIENT. AFTER THIS OCCURRED, THE PHYSICIAN WAS ABLE TO REMOVE THE BLACK TIP FROM THE PATIENT. PER HOSPITAL, A MESSAGE WITH THE PRODUCT COMPLAINT DEPARTMENT LEFT FOR RETURN OF THE DEVICE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850415 MYNX GRIP DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY F1625002

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NO| NO OTHER THERAPIES