BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL LASER

    MDR report key: 1696439 · Received May 19, 2010

    Report

    Report Number
    MW5016004
    Event Type
    Injury
    Date Received
    May 19, 2010
    Date of Event
    March 8, 2008
    Report Date
    March 11, 2010
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    ONG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD SIX SESSIONS OF FRAXEL AT THE (B) (6) SKIN INSTITUTE IN (B) (6) FOR ACNE SCARRING. OVER THE TIME OF TREATMENT, I SAW VERY LITTLE IF ANY IMPROVEMENT TO MY SKIN. THERE WAS NO CHANGE TO MY SCARS, BUT THEY SAID IT WILL COME WITH TIME. THE LAST SESSION, THE NURSE WHO PERFORMED THE TREATMENT ASKED IF I WANTED HER TO DO AN EXTRA LASER PASS. I SAID OK, CONFIDENT THAT THIS PRODUCT AND PROFESSIONAL WOULD NOT DAMAGE THE SKIN ON MY FACE. THAT NIGHT MY SKIN REACTED VERY DIFFERENTLY THAN IT DID PREVIOUS TIMES. I HAD MAJOR SWELLING AND LOADS OF CLEAR LIQUID CAME OUT OF MY SKIN. MY PILLOW WAS COVERED AND WHEN I WOKE, MY SKIN WAS TOTALLY CRUSTED OVER AND I RINSED IT OFF. OVER THE NEXT FEW DAYS, I DEVELOPED SCABS ON MY FACE THAT I AM SURE CONTRIBUTED TO NEW SCARS FORMING ON MY FACE. OVER THE NEXT FEW WEEKS, I NOTICED NEW SCARS ON MY FACE. MY FACE CONTINUALLY HAD A TINGLING SENSATION. I WENT BACK TO THE DOCTOR'S OFFICE AND THEY DID NOT HAVE ANY IDEA HOW THIS HAPPENED TO ME. THEY ALMOST DISMISSED MY CONCERN AND DID NOT LISTEN WHEN I SHOWED THEM SPECIFIC SCARS THAT WERE NEW. IT HAS BEEN TWO YEARS SINCE THIS HORRIBLE EXPERIENCE, AND IT IS STILL AFFECTING MY LIFE. I NEVER FATHOMED THAT THIS COULD EVER, EVER HAPPEN FROM DOING THE FRAXEL LASER. I ONLY WANTED SOME KIND OF IMPROVEMENT AND WHEN I GOT WAS MORE SCARS. THIS IS MY FACE AND I HAVE NO IDEA WHAT WILL HAPPEN IN THE FUTURE. I HAVE VISITED ABOUT FIVE DERMATOLOGISTS AND NO ONE HAS AN EXPLANATION. I HAVE LOST CONFIDENCE AND HAPPINESS BECAUSE OF THIS EXPERIENCE. ONE YEAR AGO, DR. (B) (6) ASKED THAT I COME IN FOR A FOLLOW UP AND HE AGAIN HAD NO EXPLANATION AND SAID I CAN ALWAYS DO PUNCH GRAFTS TO FIX THE DAMAGE? I WOULD NEVER GO BACK TO HIS OFFICE AGAIN. HE ALSO OFFERED ME MY MONEY BACK AS LONG AS I SIGNED A WAIVER. IN HIS NOTES HE MENTIONS THAT MY MOTHER ACCUSED HIM OF TREATING ME LIKE A GUINEA PIG AND HE GAVE ME MY MONEY BACK BECAUSE I WAS SO ACCUSATORY? I WAS ONLY EXPLAINING WHAT HAPPENED TO MY FACE AFTER MY LAST FRAXEL, NEW SCARS AND HOLES! HE SAYS HE POINTED OUT EACH SCAR IN A BEFORE PICTURE, THAT IS FALSE BECAUSE THEY DON'T EVEN HAVE A BEFORE PICTURE FOR ONE SIDE OF MY FACE. DATES OF USE: (B) (6) 2007 TO (B) (6) 2008. DIAGNOSIS OR REASON FOR USE: ACNE SCARRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAXEL LASER NONE ONG SOLTA MEDICAL, INC. CANNOT FIND IN FILE

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Disability