BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELITE IQ

    MDR report key: 23415300 · Received October 29, 2025

    Report

    Report Number
    1222993-2025-00051
    Event Type
    Injury
    Date Received
    October 29, 2025
    Date of Event
    October 3, 2025
    Report Date
    October 29, 2025
    Manufacturer
    EL. EN. ELECTRONIC ENGINEERING SPA
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BURNS ON THE LEG FOLLOWING A LASER HAIR REDUCTION TREATMENT USING ELITE IQ. CYNOSURE CLINICAL REACHED OUT TO THE SITE FOR ADDITIONAL INFORMATION. IT WAS DETERMINED THE USER ERROR WAS INVOLVED. OPERATOR ADMITS THAT PATIENTLY RECENTLY WENT ON A TRIP TO GREECE AND LEGS WERE STILL TAN FROM THE TRIP. OPERATOR RELAYED THEY STARTED WITH THE YAG, BUT THEN DECIDED TO CHANGE AND USE ALEX WAVELENGTH INSTEAD. PER CYNOSURE CLINICAL, "THE ALEX WAVELENGTH IS NOT APPROPRIATE FOR TANNED SKIN." IMAGES WERE PROVIDED BY THE SITE AND GIVEN TO CYNOSURE MEDICAL DIRECTOR FOR CONSULTATION. CYNOSURE MEDICAL DIRECTOR STATES THAT THE AREA HAS A FULL THICKNESS BURN AND WILL SCAR. PATIENT WAS ALSO GIVEN BIAFINE CREAM AS PREVENTATIVE MEDICATION. A SERVICE EVALUATION WAS PERFORMED BY CYNOSURE FIELD SERVICE ENGINEER (FSE) WHO CONFIRMED THE DEVICE'S OUTPUTS WERE WITHIN SPECIFICATION. BURNS ARE AN EXPECTED SIDE EFFECT FROM SUCH TREATMENT. SINCE A FULL THICKNESS BURN OCCURRED FROM THIS EVENT, THIS IS CONSIDERED A SERIOUS INJURY AND THEREFORE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212440 ELITE IQ ELITE IQ GEX EL. EN. ELECTRONIC ENGINEERING SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other