BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORPHEUS 8

    MDR report key: 23604830 · Received November 20, 2025

    Report

    Report Number
    MW5179126
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    March 30, 2023
    Report Date
    November 17, 2025
    Manufacturer
    INMODE LTD.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED TWO MORPHEUS8 RADIOFREQUENCY MICRONEEDLING TREATMENTS IN 2023. PRIOR TO THESE PROCEDURES, I HAD NORMAL FACIAL VOLUME WITH NO HISTORY OF MEDICAL CONDITIONS OR TREATMENTS THAT WOULD CAUSE FAT ATROPHY. WITHIN A FEW MONTHS AFTER THE SECOND TREATMENT, I BEGAN NOTICING PROGRESSIVE FACIAL HOLLOWING, INCLUDING LOSS OF VOLUME IN THE MIDFACE, CHEEKS, AND SURROUNDING AREAS. THE VOLUME LOSS CONTINUED TO WORSEN GRADUALLY OVER THE NEXT FEW MONTHS. AFTER SEEING THE RECENT FDA SAFETY COMMUNICATION NOTING THAT RADIOFREQUENCY MICRONEEDLING DEVICES MAY BE ASSOCIATED WITH UNINTENDED FACIAL FAT LOSS, I CONSULTED A FACIAL PLASTIC SURGEON. THE SPECIALIST EVALUATED ME AND CONFIRMED SIGNIFICANT FACIAL FAT ATROPHY, NOTING THAT THE TIMING AND PATTERN OF THE TISSUE LOSS WERE CONSISTENT WITH CHANGES THAT CAN OCCUR AFTER RADIOFREQUENCY MICRONEEDLING. THE FAT LOSS HAS HAD A SUBSTANTIAL PHYSICAL IMPACT AND HAS REQUIRED ONGOING CORRECTIVE TREATMENTS WITH A SPECIALIST TO RESTORE LOST VOLUME. THESE TREATMENTS ARE STILL IN PROGRESS AND MEDICALLY NECESSARY BECAUSE THE ATROPHY IS EXTENSIVE. I AM SUBMITTING THIS REPORT SO THE FDA IS AWARE OF MY EXPERIENCE AND CAN INCLUDE IT IN DEVICE SAFETY MONITORING FOR RADIOFREQUENCY MICRONEEDLING TECHNOLOGIES SUCH AS MORPHEUS8.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 12/16/2025 FOR REPORT MW5179126 TO REPLACE MFR AND PROCODE. PROCODE: GEI. MFR: INMODE LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076034 MORPHEUS 8 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI INMODE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention