BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCULAZE

    MDR report key: 20289411 · Received September 24, 2024

    Report

    Report Number
    3010511300-2024-00640
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    August 12, 2024
    Report Date
    September 24, 2024
    Manufacturer
    INMODE LTD.
    Product Code
    GEX
    UDI-DI
    07290016633290
    PMA / PMN Number
    K221571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO TECHNICAL ISSUES RELATED TO THE INCIDENT WERE IDENTIFIED UPON INSPECTION OF THE DEVICE. THE INVESTIGATION ATTRIBUTED THE ROOT CAUSE TO USER ERROR: THE OPERATOR TREATED A PATIENT WITH CONTRAINDICATION PER IFU: VENOUS INSUFFICIENCY. IT SEEMS THAT INITIALLY THE BURN WAS CAUSED BY FIRING TOO MANY TIMES AT THE SAME SPOT OR HITTING A LARGE VESSEL (OR A CLUSTER OF VEINS), WHICH ABSORBED ALL THE ENERGY. IT IS ALSO POSSIBLE THAT THE PROVIDER FIRED WITHOUT FULL CONTACT. FURTHER, THE LESION GOT ULCERATED AND INFECTED DUE TO VENOUS INSUFFICIENCY (ULCERATION AND INFECTION ARE KNOWN COMPLICATIONS OF VENOUS INSUFFICIENCY EVEN IN CASES OF SMALL WOUNDS). PER LATEST UPDATE, THE PATIENT IS HEALING WELL. THE CLINIC RECEIVED A RETRAINING.

    Description of Event or Problem · 0

    FULL THICKNESS BURN WITH SUBSEQUENT ULCERATION AND INFECTION ON LOWER LEG FOLLOWING TREATMENT WITH VASCULAZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1877802 VASCULAZE GEX GEX INMODE LTD. AG605988A 07290016633290

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other