BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFWAVE

    MDR report key: 23770420 · Received December 10, 2025

    Report

    Report Number
    3015889734-2025-00057
    Event Type
    Injury
    Date Received
    December 10, 2025
    Date of Event
    April 2, 2025
    Report Date
    December 10, 2025
    Manufacturer
    SOFWAVE MEDICAL LTD.
    Product Code
    OHV
    UDI-DI
    07290018152003
    PMA / PMN Number
    K250146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 10, 2025, SOFWAVE RECEIVED A REPORT FROM FDA (MW5177743) DESCRIBING PATIENT-REPORTED CHANGES INCLUDING "DEFORMED SKIN," "LOSS OF FACIAL FAT IN CHEEKS AND TEMPLE AREAS," AND "SUNKEN EYES" FOLLOWING TREATMENT. DUE TO LIMITED INFORMATION PROVIDED AND INABILITY TO CONTACT THE PATIENT FOR ADDITIONAL DETAILS, A COMPREHENSIVE INVESTIGATION COULD NOT BE COMPLETED. THE PATIENT REPORTED FACIAL FAT LOSS AFTER USE OF THE DEVICE; HOWEVER, THE MANUFACTURER'S INTERNAL REVIEW OF DESIGN SPECIFICATIONS, PERFORMANCE DATA, AND AVAILABLE CLINICAL EVIDENCE DOES NOT SUPPORT THE DEVICE'S CAPABILITY TO CAUSE SUBCUTANEOUS FAT LOSS OR TISSUE ATROPHY. THE DEVICE IS DESIGNED TO DELIVER ENERGY AT SUPERFICIAL DEPTHS (APPROXIMATELY 2 MM), WHICH ARE ABOVE THE SUBCUTANEOUS FAT LAYER. BENCH, PRECLINICAL, AND CLINICAL TESTING CONDUCTED DURING DEVELOPMENT AND POST-MARKET SURVEILLANCE HAVE NOT DEMONSTRATED POTENTIAL FOR FAT LOSS OR TISSUE ATROPHY AT THE ENERGY LEVELS AND DEPTHS DELIVERED. ADDITIONALLY, ACROSS ALL CLINICAL STUDIES CONDUCTED DURING DEVELOPMENT AND POST-MARKET EVALUATION, THERE HAVE BEEN NO REPORTED EVENTS OF FACIAL FAT LOSS OR TISSUE ATROPHY ASSOCIATED WITH THE DEVICE. SPECIFIC DEVICE HISTORY RECORDS COULD NOT BE REVIEWED DUE TO LACK OF SERIAL OR LOT NUMBER INFORMATION. THE DEVICE LABELING INCLUDES APPROPRIATE WARNINGS AND PRECAUTIONS CONSISTENT WITH ITS INTENDED USE AND KNOWN RISKS. BASED ON THE LIMITED CLINICAL, PROCEDURAL, AND PATIENT-SPECIFIC INFORMATION, THE MANUFACTURER CANNOT DETERMINE WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. IN ACCORDANCE WITH 21 CFR PART 803, THIS REPORT IS SUBMITTED OUT OF AN ABUNDANCE OF CAUTION AND IN COMPLIANCE WITH MDR REQUIREMENTS, DESPITE THE INABILITY TO CONFIRM OR EXCLUDE CAUSALITY.

    Description of Event or Problem · 0

    ON NOVEMBER 10, 2025, SOFWAVE BECAME AWARE OF REPORTABLE EVENT THAT WAS SUBMITTED TO FDA BY A PATIENT (MW5177743) ON OCTOBER 16, 2025. FDA FORWARDED THE EVENT TO SOFWAVE FOR HANDLING. PATIENT REPORTED THE FOLLOWING: "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." ADDITIONAL TREATMENT INFORMATION WAS NOT PROVIDED BY FDA AS SEVERAL FIELDS WERE REDACTED. PATIENT CONTACT INFORMATION WAS NOT AVAILABLE AND THEREFORE FURTHER FOLLOW-UP WITH THE PATIENT AND INVESTIGATION WAS NOT POSSIBLE. THE SUBJECT REPORTED THAT THE THERAPY LEFT HER "DEFORMED. SUNKEN EYES AND LOST FACIAL FAT IN MY CHEEK AND TEMPLE AREA." THE MANUFACTURER CANNOT CONFIRM WHETHER THE REPORTED CONDITION IS TEMPORARY OR PERMANENT OR RELATED TO THE DEVICE. AVAILABLE COMPLAINT INFORMATION IS LIMITED AND DOES NOT ALLOW DETERMINATION OF CAUSALITY OR CONTRIBUTION BY THE DEVICE. NO DEVICE MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042186 SOFWAVE SOFWAVE OHV SOFWAVE MEDICAL LTD. SOFWAVE 07290018152003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention