BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CONTROL

    MDR report key: 23335265 · Received October 20, 2025

    Report

    Report Number
    23335265
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 24, 2025
    Manufacturer
    ACCESS CLOSURE, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    WHEN USING MYNX CLOSURE DEVICE, THE COLLAGEN PLUG WOULD NOT DEPLOY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2820819 MYNX CONTROL DEVICE, HEMOSTASIS, VASCULAR MGB ACCESS CLOSURE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male