BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORPHEUS8

    MDR report key: 19758676 · Received July 17, 2024

    Report

    Report Number
    3010511300-2024-00567
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    June 8, 2024
    Report Date
    July 17, 2024
    Manufacturer
    INMODE LTD.
    Product Code
    GEI
    UDI-DI
    07290016633412
    PMA / PMN Number
    K200947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    TECHNICAL INSPECTION DID NOT REVEAL ANY ISSUES RELATED TO THE INCIDENT. INVESTIGATION ATTRIBUTED THE ROOT-CAUSE TO USER ERRORS AND ADDITIONAL HUMAN FACTORS: MORPHEUS8 TREATMENT WAS PERFORMED ON BLEEDING/BRUISED INJECTION SITES, WHEN THE OPERATOR SHOULD HAVE ABSTAINED FROM PERFORMING THE TREATMENT ONCE SEEING SUCH REACTION TO THE INJECTIONS. THE INJECTION OF THE ANESTHETIC SOLUTION APPARENTLY WAS DONE INCORRECTLY (TOO MUCH VOLUME, SITES TOO CLOSE TO ONE ANOTHER, POSSIBLE INCORRECT PREPARATION OF THE SOLUTION, E.G. INCORRECT CONCENTRATION OF EPINEPHRINE AND HENCE INCREASED BLEEDING). ADDITIONAL INTRINSIC FACTORS SUCH AS PATIENT'S COAGULATION PROBLEMS COULD HAVE CONTRIBUTED TO THE INCREASED BLEEDING. THE OPERATOR USED EXTREMELY AGGRESSIVE TREATMENT PARAMETERS FOR MORPHEUS8, NOT CONGRUENT WITH THE IFU, WHICH FURTHER CONTRIBUTED TO THE FORMATION OF THE LESIONS. IT SEEMS THERE WAS SOME ADDITIONAL MECHANICAL DAMAGE TO THE AREA POST TREATMENT (E.G. BY FRICTION WITH CLOTHES) AND SECONDARY INFECTION BROUGHT BY LACK OF ASEPTIC CONDITIONS POST TREATMENT.

    Description of Event or Problem · 0

    NECROTIC LESIONS AT INJECTION SITES OF ANESTHETIC SOLUTION FOLLOWING MORPHEUS8 TREATMENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706321 MORPHEUS8 GEI GEI INMODE LTD. AG607401A 07290016633412

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention