BEUDAMED
    FDA Adverse Event Other Summary report: N

    FRAXEL LASER

    MDR report key: 2747061 · Received September 11, 2012

    Report

    Report Number
    MW5026918
    Event Type
    Other
    Date Received
    September 11, 2012
    Date of Event
    November 21, 2011
    Report Date
    September 11, 2012
    Manufacturer
    PALOMER MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NON-ABLATIVE FRACTIONAL LASER DONE BY PREVEA PLASTIC SURGEONS IN (B)(6). I WAS LIED TO FROM PREVEA PLASTIC SURGEONS ABOUT THE PROCEDURE, FOR THE MONEY AND WAS NOT HELPED IN ANY WAY AFTER THE PROCEDURE WHICH LEFT MY FACE WITH SCARS, WRINKLES, CREEPY SKIN, ORANGE PEEL TEXTURE, SAGGING SKIN, LARGE PORES AND LOSS OF VOLUME. I WENT THERE BECAUSE I HAD A MILD CASE OF MELASMA ON MY CHEEKS, AND NOW AFTER 10 MONTHS MY WHOLE FACE IS RUINED. I FEEL THIS LASER SHOULD NOT BE OUT THERE ON THE MARKET BECAUSE IT AGES YOUR SKIN. PEOPLE ARE BEING DEFORMED BY THIS MACHINE, AND THEN NO ONE SEEMS TO BE ABLE TO HELP YOU ONCE YOUR FACE IS RUINED. MY DOCTOR DID NOT HELP IN ANY WAY, EVEN IN ANSWERING ANY QUESTIONS I HAD BECAUSE I BELIEVE HE DID NOT KNOW. MAYBE THERE ARE SOME DOCTORS WHO KNOW HOW TO USE THIS MACHINE PROPERLY, BUT MINE DID NOT, OR MAYBE IT¿S THE MACHINE. I HOPE YOU TAKE A BETTER LOOK AT THESE MACHINES, AND RESEARCH ONLINE UNDER (B)(6). THIS MACHINE NOT ONLY RUINS PEOPLE¿S FACES, LIVES, AND THE PEOPLE¿S LIVES AROUND THEM, PEOPLE ARE COMMITTING SUICIDE AFTER BEING DEFORMED BY THIS MACHINE. PLEASE HELP, AND STOP THIS FROM HAPPENING TO ANYONE ELSE. MY LIFE IS RUINED, LIKE SO MANY OTHERS. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAXEL LASER FRAXEL LASER GEX PALOMER MEDICAL TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other