BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIABEAUTY AGE-DEFYING LASER

    MDR report key: 3748452 · Received April 9, 2014

    Report

    Report Number
    MW5035598
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 26, 2014
    Report Date
    April 8, 2014
    Manufacturer
    TRIA BEAUTY
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED THE TRIABEAUTY AT HOME ANTI-AGING, NON-ABLATED FRAXEL LASER ON MY FACE FOR THE TREATMENT OF WRINKLES ACCORDING TO THE INSTRUCTIONS. I USED THE LASER THE NIGHT BEFORE THE EVENT AND WAS FINE THE NEXT MORNING. THE MORNING AFTER USING IT THE SECOND TIME, I NOTICED SEVERE DARKENING AND DEHYDRATION OF MY SKIN. I HAD A YELLOWISH BROWNISH SPOTS ON MY FACE. I ALSO HAD DEEP DARK MAROON LINES ON EITHER SIDE OF MY MOUTH. I STOPPED USING THE LASER IMMEDIATELY. I CONTACTED THE MANUFACTURER AND REQUESTED TO SPEAK WITH A DERMATOLOGIST OR HAVE THEM REFER ME TO ONE. THEY DID NOT RESPOND WITH A REFERRAL, EVEN THOUGH I SENT PHOTOS OF MY SKIN. ALSO, I NOTICED THAT THE DARK MAROON LINES AROUND MY MOUTH CONTINUED TO DARKEN, GET LARGER, AND MORE SEVERELY DRY THROUGHOUT THE WEEK. I WAS APPLYING NEOSPORIN TO TREAT IT. I STOPPED BY MY LOCAL (B)(6) CLINIC AND THEY GAVE ME SKIN LIGHTENING CREAM. I USED THIS FOR ONLY 2 DAYS, AS MY SKIN'S DRYNESS AND PEELING WENT INTO 'HYPER MODE.' I ALSO NOTICED THAT MY EYELIDS AND RINGS UNDERNEATH MY EYES BECAME SEVERELY DARKENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212928 TRIABEAUTY AGE-DEFYING LASER TRIABEAUTY AGE-DEFYING LASER GEX TRIA BEAUTY AGE-DEFYING LASER

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention