BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIA CLEAR BLUE LIGHT

    MDR report key: 4737374 · Received April 23, 2015

    Report

    Report Number
    MW5042340
    Event Type
    Injury
    Date Received
    April 23, 2015
    Report Date
    April 23, 2015
    Manufacturer
    TRIA BEAUTY INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED THE TRIAL CLEAR BLUE LIGHT. I JUST FINISHED THE FIRST CARTRIDGE AND HAVEN'T SEEN ANY IMPROVEMENT WITH MY MODERATE ACNE. WHAT HAS CHANGED IS THAT MY FACE IS NOW COVERED WITH RED AND BROWN SPOTS AS IF MY SKIN HAD BURNED. MY FACE LOOKS WORST THAT IT EVER HAS AND IT IS MAKING ME FEEL HORRIBLE. I TRIED TO POST A REVIEW OF THEIR WEBSITE BUT THEY REFUSED TO POST IT. NOTHING INAPPROPRIATE WAS SAID. DOSE OR AMOUNT: 5 MIN A DAY. DATES OF USE: 2 MONTHS. DIAGNOSIS OR REASON FOR USE: CLEAR MODERATE ACNE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271269 TRIA CLEAR BLUE LIGHT LASER LIGHT GEX TRIA BEAUTY INC

    Patients

    Seq Age Sex Outcome Treatment
    1