BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMARK SYSTEM

    MDR report key: 24529335 · Received March 6, 2026

    Report

    Report Number
    3016813690-2026-00002
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    January 22, 2026
    Report Date
    March 6, 2026
    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

    PATIENT EXPERIENCED SEVERE EPISTAXIS 2 WEEKS POST NEUROMARK PROCEDURE. PATIENT UNDERWENT RIGHT SPHENOPALATINE ARTERY LIGATION TO RESOLVE THE ISSUE. THERE HAS BEEN NO BLEEDING SINCE THIS PROCEDURE AND THE EVENT IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92805 NEUROMARK SYSTEM RADIOFREQUENCY PROBE GEI NEURENT MEDICAL LTD. NMK00301

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention| H