BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CONTROL ACCESS DEVICE

    MDR report key: 8707540 · Received June 17, 2019

    Report

    Report Number
    MW5087410
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    June 10, 2019
    Report Date
    June 13, 2019
    Manufacturer
    ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOLLOWING CARDIAC CATHETERIZATION MYNX CONTROL VASCULAR ACCESS CLOSURE DEVICE MALFUNCTIONED AND THE COLLAGEN PLUG DID NOT DEPLOY AS EXPECTED. MANUAL COMPRESSION WAS APPLIED TO ACCESS SITE. HAEMOSTASIS ACHIEVED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496947 MYNX CONTROL ACCESS DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC., A CARDINAL HEALTH COMPANY F1913303

    Patients

    Seq Age Sex Outcome Treatment
    1