BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORPHEUS8

    MDR report key: 21811740 · Received April 10, 2025

    Report

    Report Number
    3010511300-2025-00799
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    October 19, 2024
    Report Date
    June 30, 2025
    Manufacturer
    INMODE LTD.
    Product Code
    GEI
    UDI-DI
    07290016633412
    PMA / PMN Number
    K210492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT PRESENTING WITH PIE, PIH AND UNEVEN SKIN TEXTURE ON HER FACE 5 MONTHS FOLLOWING MORPHEUS8 TREATMENT. INVESTIGATIONS IS ONGOING.

    Additional Manufacturer Narrative · 0

    PATIENT PRESENTING WITH PIE, PIH AND UNEVEN SKIN TEXTURE ON HER FACE 5 MONTHS FOLLOWING MORPHEUS8 TREATMENT. INVESTIGATION IS ONGOING. ON 30-JUN-2025: FOLLOW-UP REPORT IS SUBMITTED WITH INVESTIGATION CONCLUSIONS. SECTION H6 HAS BEEN UPDATED. THE CLINIC CONFIRMED THAT THIS IS AN ISOLATED INCIDENT AND THEREFORE NO TECHNICAL INSPECTION OF THE DEVICE WAS PERFORMED. TREATMENT SETTINGS ARE UNKNOWN DESPITE SEVERAL ATTEMPTS TO GET THIS INFORMATION FROM THE CLINIC. DURING RETRAINING VISIT, INMODE'S TRAINER NOTICED A BAD TECHNIQUE (MOVING THE HANDPIECE BEFORE FULL NEEDLE RETRACTION). THE INITIAL INTENSE INFLAMMATORY REACTION WAS MOST PROBABLY TRIGGERED BY THE NUMBING CREAM AND EXACERBATED BY MORPHEUS8 PROCEDURE, ESPECIALLY IF THE TECHNIQUE WAS INCORRECT. THE CLINIC REPORTED THAT THE PATIENT HAS COMPLETELY HEALED.

    Description of Event or Problem · 0

    PIE, PIH AND UNEVEN SKIN TEXTURE ON FACE 5 MONTHS POST MOPRHEUS8 TREATMENT.

    Description of Event or Problem · 0

    PIE, PIH AND UNEVEN SKIN TEXTURE ON FACE 5 MONTHS POST MOPRHEUS8 TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664598 MORPHEUS8 GEI GEI INMODE LTD. AG607401A 07290016633412

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Other