BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMARK SYSTEM

    MDR report key: 13497847 · Received February 9, 2022

    Report

    Report Number
    3016813690-2022-00001
    Event Type
    Injury
    Date Received
    February 9, 2022
    Date of Event
    December 8, 2021
    Report Date
    February 7, 2022
    Manufacturer
    NEURENT MEDICAL LTD.
    Product Code
    GEI
    PMA / PMN Number
    K212666
    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

    A PATIENT TREATED WITH THE NEUROMARK SYSTEM PRESENTED WITH EPISTAXIS IN RIGHT NASAL CAVITY. SEPTOPLASTY AND CAUTERIZATION WAS PERFORMED. THE SAE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574623 NEUROMARK SYSTEM RADIOFREQUENCY PROBE GEI NEURENT MEDICAL LTD. FS-003-00 61155

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Hospitalization