BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAREIT LASER

    MDR report key: 20915706 · Received December 11, 2024

    Report

    Report Number
    MW5163565
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    November 29, 2024
    Report Date
    December 10, 2024
    Manufacturer
    SCITON, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SCITON BAREIT LASER HAIR REMOVAL LASER. I HAVE BEEN GETTING HAIR REMOVAL FOR THE PAST YEAR AND HAVE BEEN BURNED BY THE LASER ON 5 OCCASIONS. ALL IN DIFFERENT AREAS AT DIFFERENT STAGES OF THE LASER HAIR REMOVAL PROCESS EVEN WHEN THE SETTING WAS SET AS THE PREVIOUS SETTING OR BELOW IT. IT IS APPARENTLY APPROVED FOR DARKER SKIN TONES BUT I DO NOT KNOW THAT THIS IS REALLY THE CASE. BURN AREAS INCLUDE LEGS, UNDER ARMS, GLUTEUS MAXIMUS, AND BRAZILIAN AREA (TWICE). THE MEDICAL SPA WAS NOTIFIED OF EACH BURN AND THEY SAID THAT BURNS CAN HAPPEN BUT DID NOT SEEM BOTHERED BY THIS (THE BUSINESS OWNER). I AM NOT SURE IF THEY HAVE EVER REPORTED THE BURNS THAT I HAVE COME TO THEM ABOUT THEREFORE I AM DOING MY DUE DILIGENCE. BURNS ARE STILL VISIBLE IN ALL AREAS AND WILL NEED TO EITHER BE TREATED WITH AN EXFOLIANT OR SKIN LIGHTENING PRODUCT. BURNS IN TWO OF THE AREAS CAUSED EXTREME IRRITATION AND ITCHING FOR ONE WEEK (BUTT AND BRAZILIAN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2377020 BAREIT LASER POWERED LASER SURGICAL INSTRUMENT GEX SCITON, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention NOW HYDROQUINONE AND TRETINOIN (ON FACE).