BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORPHEUS8

    MDR report key: 24870274 · Received April 14, 2026

    Report

    Report Number
    3010511300-2026-01053
    Event Type
    Injury
    Date Received
    April 14, 2026
    Date of Event
    July 1, 2025
    Report Date
    April 14, 2026
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    A FEMALE PATIENT WITH SKIN TYPE II TREATED ON HER FACE WITH MORPHEUS8 AND PRESENTING WITH PIH/PIE OVER HER FACE THAT REPLICATE MORPHEUS8 TIP FOOTPRINTS, 8 MONTHS POST TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933463 MORPHEUS8 GEI GEI INMODE LTD. AG607401A 07290016633412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other