BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL SR

    MDR report key: 2437850 · Received January 28, 2012

    Report

    Report Number
    MW5024061
    Event Type
    Injury
    Date Received
    January 28, 2012
    Date of Event
    September 14, 2009
    Report Date
    January 28, 2012
    Manufacturer
    SOLTA MEDICAL
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MY LASER "EXPERT" DOCTOR BURNED MY FACE WITH FRAXEL REPAIR SR1500. HE PARTICIPATED IN THE RESEARCH TO GET THIS LASER APPROVED BY THE FDA; RUSHED THROUGH VIA THE 510 K PROCESS. THERE WAS ALSO A DISCHARGE OF ENERGY AT THE BEGINNING OF THE PROCEDURE WHICH SENT A POWERFUL ELECTRICAL SHOCK THROUGH THE LEFT SIDE OF MY FACE. I HAD MORE COLLAGEN ATROPHY ON THIS SIDE, MORE FATTY NECROSIS (FAT CELL DEATH), AND MORE FIBROTIC SCARRING. IT LITERALLY CHANGED THE SHAPE OF MY ENTIRE FACE, BUT WORSE ON THE LEFT SIDE WHERE THIS EXCESS DISCHARGE OF ENERGY WENT THROUGH MY FACE. MY BODY JUMPED INVOLUNTARILY OFF THE TABLE AND HE SAID NOT TO BE CONCERNED, THAT IT WAS JUST CALIBRATING. HE PROCEEDED TO THEN DISPENSE 40 MJS OF ENERGY ALL OVER MY FACE, GOING OVER THE AREA THAT HAD JUST BEEN SHOCKED. I MERGED WITH A DRIPPING, BLOODY FACE. THE "WORST CARE SCENARIO" WAS ADVERTISED BY THE DOCTOR AND THE LASER COMPANY, (B)(6), AS "REDNESS LIKE A MILD SUNBURN." I HAVE PERMANENT DAMAGE TO INCLUDE, DENTS, PITS, NERVE PALSY, EYEBALL RETRACTION FROM FAT LOSS AROUND THE EYE SOCKETS, FIBROTIC SCARRING, FATTY NECROSIS AND RADIATION DAMAGE WHICH CAUSED MY FACE TO SHRUNK IN SIZE AND LAYERS OF SKIN WARPED AND MELTED TOGETHER CAUSING A SHRINK WRAPPED LOOK AND FELL. I HAVE BLACK DISCOLORATION "SCARS" AND HYPERPIGMENTATION STREAKS DOWN MY FACE. ALSO HYPOPIGMENTATION (AKA MELANOCYTE DEATH) WHICH RENDERS MY TYPE I SKIN UNABLE TO DEFEND ITSELF AGAINST UV AND INCREASE MY RISK OF SKIN CANCER. I SUSTAINED STRETCHED OUT PORES, PHOTOAGING, AND AM NOW ALLERGIC TO THE SUN. THIS EXTREME PHOTOSENSITIVITY IS PERMANENT AND CAUSES HIVES UPON SUN EXPOSURE. IT DESTROYED MY LIPID BARRIER, WHICH RENDERS MY SKIN UNABLE TO CARRY OUT ITS BASIC FUNCTIONS. IT IS DRIED LIKE SANDPAPER. I WAS ONLY 33 WHEN THIS HAPPENED. I AM NOW TAKING MEDICATIONS FOR 3 DIFFERENT LASER INDUCED SKIN "DISEASES." I HAVE HAD PROBLEMS SENSING TEMPERATURE IN MY FACE (CAN FEEL TEMP OF WATER IN HANDS BUT NOT ON MY FACE WHILE WASHING MY FACE). I HAVE CHRONIC PAIN IN MY FACE IN THE FORM OF NERVE SHOCK SENSATIONS. MORE THAN HALF OF WHAT I DESCRIBED HEREIN WAS NOT ON MY CONSENT FORM. THIS WAS AND IS AN FDA APPROVED DEVICE. I HAVE ONLY HAD THIS ONE "TREATMENT". NONE BEFORE OR SINCE. FRAXEL REPAIR WAS USED ALL OVER ENTIRE FACE. ALEXANDRITE LASER WAS USED ON RIGHT SIDE, ON ONE PIGMENT SPOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAXEL SR REPAIR LASER GEX SOLTA MEDICAL 1500 ASK DR. GROFF

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention| S