BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORPHEUS 8

    MDR report key: 17379134 · Received July 24, 2023

    Report

    Report Number
    3010511300-2023-00220
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    December 19, 2022
    Report Date
    July 24, 2023
    Manufacturer
    INMODE LTD
    Product Code
    GEI
    UDI-DI
    07290016633672
    PMA / PMN Number
    K210492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    08/21/2023. G3 - DATE RECEIVED BY MANUFACTURER WAS CORRECTED TO 04/19/2023 TO REFLECT THE INITIAL AWARENESS DATE, HOWEVER, AT THAT MOMENT THE SKIN REACTION WAS ASSESSED AS NON REPORTABLE SINCE CONTEMPLATED WITHIN EXPECTED AND ACCEPTABLE SIDE EFFECT. LATER ON, AN UPDATE WAS RECEIVED BY THE PATIENT STATING PROLONGED PIE/PIH AND THERFORE IT WAS DECIDED TO REPORT THIS AE.

    Additional Manufacturer Narrative · 0

    INITIALLY THE PATIENT CONTACTED INMODE DIRECTLY VIA EMAIL, CONSEQUENTLY WE IDENTIFIED THE CLINIC THAT PROVIDED THE SERVICE AND WE RECEIVED INFORMATION RELATING TO THIS THE AE (CCQ) THEREFORE IN ADDITION TO THE PATIENT DETAILS (INITIAL REPORTER) WE HEREBY REPORT THE CLINIC DETAILS AS WELL: (B)(6). INVESTIGATION RESULTS: USER ERROR; TOO AGGRESSIVE TREATMENT PARAMETERS (83MJ/PIN) AND 3MM ON NECK, (67 MJ/PIN) 2MM ON FOREHEAD. INTERVALS BETWEEN TREATMENTS WERE TOO SHORT WHICH DID NOT ALLOW THE SKIN TO RECOVER BEFORE NEXT TREATMENT. PHOTOS BEFORE 2ND AND 3RD TREATMENT SHOW SKIN THAT SHOULD NOT UNDERGO TREATMENT DUE TO AN INCOMPLETE RECOVERY. POST TREATMENT APPLICATION OF AGGRESSIVE SUBSTANCES THAT DID NOT ENABLE HEALING (ENZYMATIC PEEL, AHA SERUM, HYDROQUINONE, ALUMIER RECOVERY BALM). IN SUMMARY, AGGRESSIVE TREATMENT PARAMETERS, INTERVALS BETWEEN TREATMENTS TOO SHORT, APPLICATION OF AGGRESSIVE SUBSTANCES ON SKIN FOLLOWING TREATMENT WHICH DID NOT ALLOW SKIN RECOVERY.

    Description of Event or Problem · 0

    A WIDESPREAD POST-INFLAMMATORY ERYTHEMATOUS STATE OVER THE ENTIRE FACE AND NECK 7 MONTHS AFTER TREATMENT WITH M8. THE FOOTPRINTS IN THE SHAPE OF THE TIP MATRIX ARE OBSERVABLE. POST-INFLAMMATORY HYPERPIGMENTATION IS ALSO VISIBLE AT THE NEEDLE INSERTION POINTS. THE CLINICAL PICTURE WOULD APPEAR TO BE A COMPROMISED AND ALTERED HEALING PROCESS. ACCORDING TO THE UPDATED INFORMATION RECEIVED FROM THE PATIENT, THE PIE REACTION HAS NOT SUBSIDED AFTER 7 MONTHS. DUE TO THE LONGEVITY OF THE REACTION, IT WAS DECIDED TO REPORT THIS EVENT.

    Description of Event or Problem · 0

    A WIDESPREAD POST-INFLAMMATORY ERYTHEMATOUS STATE OVER THE ENTIRE FACE AND NECK 7 MONTHS AFTER TREATMENT WITH M8. THE FOOTPRINTS IN THE SHAPE OF THE TIP MATRIX ARE OBSERVABLE. POST-INFLAMMATORY HYPERPIGMENTATION IS ALSO VISIBLE AT THE NEEDLE INSERTION POINTS. THE CLINICAL PICTURE WOULD APPEAR TO BE A COMPROMISED AND ALTERED HEALING PROCESS. ACCORDING TO THE UPDATED INFORMATION RECEIVED FROM THE PATIENT, THE PIE REACTION HAS NOT SUBSIDED AFTER 7 MONTHS. DUE TO THE LONGEVITY OF THE REACTION, IT WAS DECIDED TO REPORT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993768 MORPHEUS 8 GEI GEI INMODE LTD AG607401A 07290016633672

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Other