BEUDAMED
    FDA Adverse Event Other Summary report: N

    BEUTICONTROL

    MDR report key: 3846027 · Received May 28, 2014

    Report

    Report Number
    MW5036423
    Event Type
    Other
    Date Received
    May 28, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 16, 2014
    Manufacturer
    BEAUTICONTROL
    Product Code
    NZF
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY MOTHER TOLD ME ABOUT A PRODUCT CALLED OXYGENZONE FROM A COMPANY CALLED BEAUTICONTROL. THE PRODUCT CLAIMS IT PRODUCES OZONE (O3) FOR HEALTH BENEFITS. THE PROBLEM WITH THIS IS THAT OZONE IS TOXIC TO PRETTY MUCH ALL BIOLOGICAL LIFE INCLUDING PEOPLE. MY MOTHER CLAIMS HER SKIN GETS RED AFTER USING THE PRODUCT, WHICH IS A SIGN OF IRRITATION, AND I'M WORRIED THIS THING IS DAMAGING HER AND OTHERS. IT'S A SKIN CARE DEVICE CLAIMING ALL MANNER OF NONSENSE WHILE SIMULTANEOUSLY EXPOSING PEOPLE TO OZONE, WHICH IS NOT SAFE. THE PREMISE IS THAT YOU RUB YOUR SKIN WITH THIS WAND OF SORTS FOR HEALTH BENEFITS, BUT FROM WHAT I CAN TELL ALL IT DOES IS IRRITATE THE SKIN. BECAUSE IT'S HARMFUL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314807 BEUTICONTROL BEUTICONTROL NZF BEAUTICONTROL OXYGENZONE

    Patients

    Seq Age Sex Outcome Treatment
    1