BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION

    MDR report key: 23221655 · Received October 6, 2025

    Report

    Report Number
    MW5176922
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 22, 2025
    Report Date
    September 30, 2025
    Manufacturer
    SOFWAVE MEDICAL LTD.
    Product Code
    OHV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6), I UNDERWENT A SOFWAVE PROCEDURE OF THE NECK AND FACE. THE PROBE HAS LEFT A STAMP ON MY FACE IN THE SHAPE OF AN H THAT IS NOT RESOLVING. THE PROVIDER WAS VERY UPSET AND SAID ALL SETTINGS WERE CORRECT. SOFWAVE TOLD THE PROVIDER THE PROBE WAS FAULTY AND PROVIDED HER A NEW ONE. SOFWAVE IS MARKETED AS A SAFE "ORGANIC" TREATMENT. I QUITE POSSIBLY HAVE BECOME PERMANENTLY DISFIGURED FROM SOFWAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343493 FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION OHV SOFWAVE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention