BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORPHEUS8

    MDR report key: 20188834 · Received September 11, 2024

    Report

    Report Number
    3010511300-2024-00617
    Event Type
    Injury
    Date Received
    September 11, 2024
    Date of Event
    December 27, 2023
    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
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FEMALE PATIENT PRESENTS WITH PIE AND PIH ON HER ABDOMEN ALMOST 8 MONTHS POST MORPHEUS8 TREATMENT. INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    FEMALE PATIENT PRESENTS WITH PIE AND PIH ON HER ABDOMEN ALMOST 8 MONTHS POST MORPHEUS8 TREATMENT. INVESTIGATION IS ONGOING. (B)(6) 2024: FOLLOW UP REPORT IS SUBMITTED WITH INVESTIGATION CONCLUSIONS. THE DEVICE WAS NOT INSPECTED AS THE CLINIC CONFIRMED THEY HAVE BEEN USING THE DEVICE WITHOUT ANY ISSUES AND THIS IS AN ISOLATED INCIDENT. THE INVESTIGATION CONCLUDED THAT THE PROLONGED PIE/PIH WERE A RESULT OF DELAYED HEALING DUE TO SEVERAL FACTORS. FIRST, THE INITIAL INFLAMMATORY RESPONSE COULD HAVE BEEN TRIGGERED BY APPLICATION OF A NUMBING CREAM WITH HIGH PERCENTAGE OF ANESTHETICS AND PATIENT'S INDIVIDUAL HYPERSENSITIVITY. THE HEALING IN GENERAL IS USUALLY DELAYED IN SUCH PERIPHERAL AREAS, ESPECIALLY WITH INCREASED SKIN LAXITY SUCH AS OF THIS PATIENT, SINCE SUCH SKIN HAS POORER CIRCULATORY EFFICIENCY. HOWEVER, THE HEALING WAS PERTURBED FURTHER BY MULTIPLE ADDITIONAL PROCEDURES DONE BY THE PROVIDER AFTER MORPHEUS8 TREATMENT: APPLICATION OF A CREAM CONTAINING MULTIPLE ACTIVE SUBSTANCES INTERFERING WITH THE HEALING PROCESS, IPL TREATMENT, AND THREE FRACTIONAL THULIUM LASER TREATMENTS. ALL THIS CONTRIBUTED TO INFLAMMATION, INTERFERED WITH THE NORMAL HEALING PROCESS AND LED TO THE OBSERVED PIE/PIH.

    Description of Event or Problem · 0

    PIE AND PIH ON ABDOMEN 8 MONTHS POST MORPHEUS8 TREATMENT.

    Description of Event or Problem · 0

    PIE AND PIH ON ABDOMEN 8 MONTHS POST MORPHEUS8 TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567175 MORPHEUS8 GEI GEI INMODE LTD. AG609126A 07290016633672

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Other