BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MORPHEUS8

    MDR report key: 19788610 · Received July 21, 2024

    Report

    Report Number
    3010511300-2024-00574
    Event Type
    Injury
    Date Received
    July 21, 2024
    Date of Event
    October 16, 2023
    Report Date
    November 26, 2024
    Manufacturer
    INMODE LTD.
    Product Code
    GEI
    UDI-DI
    07290016633412
    PMA / PMN Number
    K210492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT COMPLAINED TO INMODE ABOUT HAVING PIE/PIH OVER HER FACE 9 MONTHS POST MORPHEUS 8 TREATMENT. DURING THE INVESTIGATION IT WAS REVEALED THAT THE TREATMENT PROVIDER IS NOT AN INMODE CUSTOMER AND DID NOT UNDERGO A TRAINING BY INMODE. TREATMENT SETTINGS UTILIZED BY THE PROVIDER WERE NOT IN CONGRUENCE WITH THE RECOMMENDED PROTOCOL. ACCORDING TO THE PATIENT, SHE WAS ALSO RECOMMENDED BY THE PROVIDER TO APPLY VITAMIN C SERUM POST TREATMENT, WHICH CONTRIBUTED TO THE INFLAMMATION AND DELAYED THE HEALING. ADDITIONALLY, THE PATIENT UNDERWENT LASER TREATMENTS AT A DIFFERENT CLINIC AFTER MORPHEUS8 PROCEDURE ON THE SKIN THAT HAS NOT HEALED YET, PROMOTING THE INFLAMMATORY PROCESS. ALL THESE FACTORS CONTRIBUTED TO THE DELAYED HEALING AND THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 0

    THE PATIENT COMPLAINED TO INMODE ABOUT HAVING PIE/PIH OVER HER FACE 9 MONTHS POST MORPHEUS8 TREATMENT. DURING THE INVESTIGATION IT WAS REVEALED THAT THE TREATMENT PROVIDER IS NOT AN INMODE CUSTOMER AND DID NOT UNDERGO A TRAINING BY INMODE. TREATMENT SETTINGS UTILIZED BY THE PROVIDER WERE NOT IN CONGRUENCE WITH THE RECOMMENDED PROTOCOL. ACCORDING TO THE PATIENT, SHE WAS ALSO RECOMMENDED BY THE PROVIDER TO APPLY VITAMIN C SERUM POST TREATMENT, WHICH CONTRIBUTED TO THE INFLAMMATION AND DELAYED THE HEALING. ADDITIONALLY, THE PATIENT UNDERWENT LASER TREATMENTS AT A DIFFERENT CLINIC AFTER MORPHEUS8 PROCEDURE ON THE SKIN THAT HAS NOT HEALED YET, PROMOTING THE INFLAMMATORY PROCESS. ALL THESE FACTORS CONTRIBUTED TO THE DELAYED HEALING AND THE REPORTED CONDITION. 19-NOV-2024: FOLLOW-UP REPORT IS SUBMITTED WITH ADDITIONAL INFORMATION AND CORRECTION. D4- SERIAL NUMBER WAS CORRECTED. THE PROVIDER HAS BEEN ESTABLISHED AS INMODE CUSTOMER AND RECEIVED AN OFFICIAL TRAINING BY INMODE. THE DEVICE WAS INSPECTED 1 YEAR AFTER THE INCIDENT. THE TECHNICAL ISSUE REVEALED DURING TECHNICAL INSPECTION WAS CONCLUDED TO BE NOT RELATED TO THE INCIDENT, BASED ON PROVIDER'S CONFIRMATION THAT SINCE THE INCIDENT IN (B)(6) 2023 HUNDREDS OF PATIENTS HAVE BEEN TREATED WITH NO ISSUES. INVESTIGATION CONCLUDED THE ROOT CAUSE TO BE THE INCORRECT TREATMENT PROTOCOL UTILIZED BY THE PROVIDER AND MULTIPLE ADDITIONAL AGGRESSIVE PROCEDURES AND SUBSTANCES APPLIED POST TREATMENT, WHICH PERTURBED THE NORMAL HEALING PROCESS.

    Description of Event or Problem · 0

    PIH/PIE OVER FACE 9 MONTHS POST MORPHEUS 8 TREATMENT.

    Description of Event or Problem · 0

    PIH/PIE OVER FACE 9 MONTHS POST MORPHEUS8 TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479851 MORPHEUS8 GEI GEI INMODE LTD. AG607401A 07290016633412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other