BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMARK SYSTEM

    MDR report key: 25150290 · Received May 12, 2026

    Report

    Report Number
    MW5188038
    Event Type
    Injury
    Date Received
    May 12, 2026
    Report Date
    May 11, 2026
    Manufacturer
    NEURENT MEDICAL LIMITED
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED ABOUT NEURENT MEDICAL NEUROMARK SYSTEM. REPORTER EXPLAINED THAT THEY HAD THE NEUROMARK PROCEDURE DONE IN (B)(6) 2026. DAMAGED THEIR CRANIAL NERVE. SAYS THAT THEY ARE IN CONSTANT PAIN ON THEIR LEFT SIDE AND CONSTANT HEADACHE ON THEIR RIGHT SIDE. EXPLAINED THAT THEY CANNOT FUNCTION ON A DAILY BASIS DUE TO CONSTANT PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525727 NEUROMARK SYSTEM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI NEURENT MEDICAL LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Other