BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORPHEUS8

    MDR report key: 20246410 · Received September 18, 2024

    Report

    Report Number
    3010511300-2024-00631
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    July 31, 2024
    Report Date
    September 29, 2024
    Manufacturer
    INMODE LTD.
    Product Code
    GEI
    UDI-DI
    07290016633672
    PMA / PMN Number
    K200947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FULL THICKNESS BURNS ON A FEMALE PATIENT TREATED WITH MORPHEUS8. INVESTIGATION IS ONGOING. (B)(6) 2024: FU REPORT IS SUBMITTED WITH INVESTIGATION CONCLUSIONS. TECHNICAL INSPECTION OF THE DEVICE DID NOT REVEAL ANY ISSUES THAT COULD HAVE LED TO THE REPORTED BURN. INVESTIGATION ATTRIBUTED THE ROOT CAUSE TO USER ERROR: THE TREATMENT SETTINGS WERE EXTREMELY AGGRESSIVE AND COMPLETELY NOT CONGRUENT WITH THE IFU. MULTIPLE PASSES WERE DONE AT MULTIPLE DEPTHS, WITH ENERGY EXCEEDING THE RECOMMENDED, PULSING WAS DONE WITH HIGH OVERLAP, WITH MULTIPLE PULSES ON THE SAME SPOT AND EXTREMELY HIGH NUMBER OF TOTAL PULSES. ALL THIS COMBINED WITH PATIENT NOT HAVING A THICK FAT LAYER. SUCH EXCESS OF ENERGY ON THE SAME SPOT LED THE OBSERVED THERMAL TISSUE DAMAGE AND NECROSIS. CURRENTLY, THE PATIENT IS HEALING WELL AND THE CLINIC HAS BEEN RETRAINED.

    Additional Manufacturer Narrative · 0

    FULL THICKNESS BURNS ON A FEMALE PATIENT TREATED WITH MORPHEUS8. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    FULL THICKNESS BURNS ON GLUTEAL FOLD AND THIGHS.

    Description of Event or Problem · 0

    FULL THICKNESS BURNS ON GLUTEAL FOLD AND THIGHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227200 MORPHEUS8 GEI GEI INMODE LTD. AG609126A 07290016633672

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other