BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE IQ

    MDR report key: 19643406 · Received July 1, 2024

    Report

    Report Number
    1222993-2024-00034
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    June 1, 2024
    Report Date
    July 1, 2024
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    UDI-DI
    08057017760450
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN, PRONOUNCED EDEMA, AND BLISTERS ON THE UPPER LIP FOLLOWING A LASER HAIR REDUCTION TREATMENT USING ELITE IQ. PATIENT MOVED AND LASER WAS PULSED INSIDE THE VERMILLION BORDER. PATIENT WAS GIVEN 1% HYDROCORTISONE AND FUCIDIN AS PREVENTATIVE MEDICATION. PATIENT WAS ALSO PRESCRIBED ORAL STEROID, BUT DID NOT TAKE THE MEDICATION. PATIENT REPORTED VISITING THE EMERGENCY ROOM AND RECEIVING AN ANTI-INFLAMMATORY INJECTION. TREATMENT SETTINGS USED WERE WITHIN GUIDELINES, ALTHOUGH AGGRESSIVE. CYNOSURE MEDICAL DIRECTOR REVIEWED THE INCIDENT AND ADVISE ORAL STEROID AND A FOLLOW UP WITH A DERMATOLOGIST OR PLASTIC SURGEON. SITE CONFIRMS PATIENT IS ALMOST HEALED DURING A FOLLOW UP VISIT ON (B)(6) 2024. THE DEVICE WAS EVALUATED AND FOUND TO BE OPERATING AS INTENDED WITHIN SPECIFICATION. PAIN, EDEMA, AND BLISTER ARE EXPECTED SIDE EFFECTS FROM LASER TREATMENTS, HOWEVER THIS EVENT IS REPORTABLE DUE TO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616589 ELITE IQ ELITE IQ GEX EL. EN. ELECTRONIC ENGINEERING SPA 08057017760450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention