BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFTWAVE

    MDR report key: 23350623 · Received October 21, 2025

    Report

    Report Number
    MW5177743
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    April 2, 2025
    Report Date
    October 16, 2025
    Manufacturer
    SOFWAVE MEDICAL LTD.
    Product Code
    OHV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    I HAD 2 SOFTWAVE SKIN TIGHTENING TREATMENTS ON MY FACE BY DR. (B)(6). I WAS TOLD THERE ARE NO SERIOUS SIDE EFFECTS AND THIS IS A MINIMALLY INVASIVE TREATMENT THAT IS SUPPOSED TO HELP TIGHTEN MY SKIN AND IMPROVE THE QUALITY. INSTEAD, IT LEFT ME DEFORMED. MY EYES SUNKEN AND I LOST FACIAL FAT IN MY CHEEK AND TEMPLE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2730406 SOFTWAVE FOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION OHV SOFWAVE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention