BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAIT TECHNOLOGY, INC

    MDR report key: 1216524 · Received October 27, 2008

    Report

    Report Number
    MW5008814
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    December 22, 2006
    Report Date
    October 27, 2008
    Manufacturer
    RELAIT TECHNOLOGY, INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THIS IS A SHORT SUMMARY OF THE PROBLEM. I WENT TO SEE DR. IN 2005 TO HELP CLEAR UP ACNE AND ACNE SCARS. HE STARTED ME OFF WITH BLEACHING CREAM TO SEE IF THAT WOULD CLEAR THE ACNE SCARS BUT IT DIDN'T WORK. IN LATE 2006, DR. THEN RECOMMENDED TO TRY THE LASER FRAXEL -MADE BY RELIANT TECHNOLOGY BASE IN MTN. VIEW- BECAUSE OF MY HISPANIC BACKGROUND AND SKIN COLOR IT WOULD BE SAFE FOR MY SKIN. I HAD THE FIRST TREATMENT ON THE SAME MONTH - JUST THE CHEEKS AND UPPER LIP AREA WAS DONE AT THAT TIME. MY CHEEK AREA WAS FINE FOR THE FEW MOS, BUT THE UPPER LIP HAD INFLAMMATION AND HYPER PIGMENTATION SOON AFTER THE TREATMENT. SO I TRIED ANOTHER TREATMENT IN 2007 TO CORRECT THE HYPER PIGMENTATION THAT OCCURRED FROM THE FIRST TREATMENT, IT LIGHTENED UP A BIT. BUT AFTER THE SECOND TREATMENT, I HAD TO USE BLEACHING CREAM AND TAZORAC TO TRY TO IMPROVE THE COLOR MORE. FOR A FEW MOS, IT LOOKED OKAY BUT NOT GREAT. BUT AS THE MOS WENT ON, THE HYPER PIGMENTATION STARTED TO GET DARKER ON MY UPPER LIP AND MY CHEEKS. I HAVE BEEN USING SUN SCREEN EVERYDAY TO PROTECT MY SKIN. I HAVE BEEN WORKING WITH DR FOR THE PAST 1YR AND 10MOS TO CORRECT THE PROBLEM, BUT NOTHING HAS BEEN HELPING. I HAD A SECOND OPINION DONE BY ANOTHER DR AND HE SUGGESTED THAT FIRST DR CONTACT RELIANT TECHNOLOGY, INC. FOR SOME HELP SOLVING THE PROBLEM, SINCE THEY ARE THE MAKER OF THE LASER FRAXEL MACHINE. DR'S GROUP STARTED THE BALL ROLLING AND OBTAINED THE NAME OF AN INSIDE SALES PERSON, BY RELIANT TECHNOLOGIST TO GET SOME HELP WITH THE HYPER PIGMENTATION. DR'S GROUP HAS CALLED A FEW TIMES AND NO LUCK. SO I TRIED A FEW TIMES AND ABOUT THE THIRD TIME A GOT A HOLD OF RELIANT TECHNOLOGY. AS OF TODAY TECHNOLOGIST HAS NOT RECEIVED MY FILE FROM FIRST DR'S GROUP FOR REVIEW. I HAVE HAD NO CALL FROM DR'S GROUP LETTING ME KNOW IF THERE HAS BEEN ANY DISCUSSION TO HOW TO SOLVE THE HYPER PIGMENTATION ON MY FACE. I'M GETTING MADE BECAUSE I ONLY HAVE ONE FACE I CANNOT GROW A NEW FACE TO REPLACE THE ONE I HAVE. I HAVE TO COVER MY FACE WHEN I GO SNOW SKIING, OUT ON THE BOAT, AND HIKING/RUNNING TO KEEP FROM GETTING DARKER. DATES OF USE: 2006- 2007. DIAGNOSIS OR REASON FOR USE: TO CLEAR ACNE SCARS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELAIT TECHNOLOGY, INC FRAXEL LASER GEX RELAIT TECHNOLOGY, INC KNOWN KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention