BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMARK SYSTEM

    MDR report key: 23355581 · Received October 22, 2025

    Report

    Report Number
    3016813690-2025-00001
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 21, 2025
    Report Date
    October 22, 2025
    Manufacturer
    NEURENT MEDICAL LTD.
    Product Code
    GEI
    PMA / PMN Number
    K250048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLEEDING IS A KNOWN POTENTIAL ADVERSE EVENT AND IS DOCUMENTED IN THE DEVICE LABELLING.

    Description of Event or Problem · 0

    THE FEMALE PATIENT WAS TREATED WITH THE NEUROMARK SYSTEM IN EARLY (B)(6) 2025. APPROXIMATELY 3 WEEKS AFTER THE PROCEDURE, THE PATIENT HAD A LATE BLEED WHICH NEEDED HOSPITALIZATION AND BLOOD TRANSFUSION. THE EVENT IS RESOLVED AND PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232118 NEUROMARK SYSTEM RADIOFREQUENCY PROBE GEI NEURENT MEDICAL LTD. NMK00301 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization