BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 2100

    MDR report key: 18639183 · Received February 5, 2024

    Report

    Report Number
    9615085-2024-00002
    Event Type
    Injury
    Date Received
    February 5, 2024
    Date of Event
    January 6, 2024
    Report Date
    February 5, 2024
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    NRZ
    PMA / PMN Number
    P040003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO SYSTEM MALFUNCTION. TREATMENT PARAMETERS WERE IN LINE WITH THE TYPICAL RANGE. NO NEW RISKS WERE IDENTIFIED. SKIN BURN IS A KNOWN SIDE EFFECT OF TREATMENT. THIS MEDWATCH IS BEING SUBMITTED ALTHOUGH ADENOMYOSIS IS NOT AN APPROVED INDICATION IN THE US, BECAUSE THIS SIDE EFFECT MAY BE RELEVANT TO GENERAL UTERINE FIBROID TREATMENT.

    Description of Event or Problem · 0

    PATIENT ENDURED TWO BLISTERS (SIZE 2.5 X 2.5 CM) ON THE ABDOMEN IMMEDIATELY FOLLOWING ADENOMYOSIS TREATMENT. MEDICATION (COMPOUND POLYMYXIN B OINTMENT) WAS APPLIED TO THE BLISTERS. PATIENT WAS DISCHARGED ON THE 2ND DAY AFTER THE TREATMENT FOLLOWING SKIN BURN PAIN RELIEF AND FADED COLORING OF THE BLISTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278463 EXABLATE 2100 MR GUIDED FOCUSED ULTRASOUND SYSTEM NRZ INSIGHTEC LTD. 2100

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Disability