BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMARK SYSTEM

    MDR report key: 17265107 · Received July 6, 2023

    Report

    Report Number
    3016813690-2023-00001
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    June 18, 2023
    Report Date
    July 6, 2023
    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

    PATIENT UNDERWENT NEUROMARK PROCEDURE ON (B)(6) 2023. ON (B)(6) 2023 (23 DAYS POST PROCEDURE) THE PATIENT EXPERIENCED LEFT SIDED POSTERIOR EPISTAXIS FROM SPHENOPALATINE ARTERY BRANCH. THE PATIENT WAS TAKEN TO OR FOR LEFT SPHENOPALATINE ARTERY LIGATION. THE PATIENT WAS DISCHARGED FROM HOSPITAL LESS THAN 12 HOURS AFTER SPA LIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932018 NEUROMARK SYSTEM RADIOFREQUENCY PROBE GEI NEURENT MEDICAL LTD. FS-002-01

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention