BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL RESTORE LASER

    MDR report key: 1678103 · Received May 4, 2010

    Report

    Report Number
    MW5015841
    Event Type
    Injury
    Date Received
    May 4, 2010
    Date of Event
    July 29, 2009
    Report Date
    May 4, 2010
    Manufacturer
    SOLTA MEDICAL, INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WENT TO SEE DR (B) (6) - (B) (6)- ON (B) (6) 2009 TO IMPROVE 20 YEAR OLD SCARS THAT WERE KIND OF WHITE OVER MANY YEARS OF TIME. I HAD ALSO HAD A BEAUTIFUL REVISION DONE IN ONE AREA. I THOUGHT THE LASER WOULD IMPROVE THE SCARS AND MAKE THEM GO AWAY LIKE IT SAYS IN AN ARTICLE THAT WAS PUBLISHED ON HIM. HE SAID THAT HE WOULD USE THE FRAXEL RESTORE LASER ON THESE SCARS AND THAT HE COULD IMPROVE THEM, ETC. HE SAID THAT THEY WOULD BE RED FOR 5-7 DAYS AT MOST, AND THAT I WOULD NEED MULTIPLE TREATMENTS. I HAD A TERRIBLE EXPERIENCE WITH THIS LASER AND IT HAS RUINED MY LIFE. IT HAS BEEN OVER 9 MONTHS NOW AND MY SCARS ARE BIGGER, WIDER, AND DARKER - MUCH MORE NOTICEABLE AND DISCOLORED THEN THEY WERE, AND THE SKIN IN THE AREA LOOKS STRANGE. NOW THE AREA SURROUNDING THE SCARS IN SOME AREAS IS DISCOLORED. FOR ME THIS WAS A TERRIBLE EXPERIENCE AND I CAN NOT BELIEVE I PAID SOMEONE TO DO THIS TO ME. WHEN I COMPLAINED ALL THEY COULD SAY IS IT LOOKS MUCH BETTER...AND THEY KEEP REPEATING THAT - JUST LOOK AT THE PICTURES. THIS GUY MADE (B) (6) WHICH HE ACTUALLY REFUNDED ME. I WANTED HIM TO TRY TO FIX THE DAMAGE THAT HE DID, BUT HE HAS REFUSED TO TRY TO HELP ME WITH THE SITUATION. I AM WRITING THIS SO SOMEONE ELSE DOES NOT DECIDE TO DO THIS AND HAVE TO GO THROUGH WHAT I AM GOING THROUGH. I LOOK IN THE MIRROR EVERY MORNING, BUT IT LOOKS WORSE EVERY DAY AND I CRY EVERY DAY. THE NEPHEW OF THE DR THAT DID MY PREVIOUS SURGERY ABOUT 20 YEARS AGO - WHO NOW DOES THE SAME SURGERY - SAID THAT HAD I GONE TO SEE HIM BEFOREHAND ABOUT DOING THE LASER PROCEDURE THAT HE WOULD HAVE TOLD ME NOT TO DO IT. I AM SEEING HIM AGAIN NEXT WEEK TO SEE IF THERE IS ANYTHING I CAN DO. I AM TRYING TO DECIDE WHETHER TO PURSUE THIS LEGALLY BECAUSE OF THIS DR AND NOT ONLY OF HIS TREATMENT OF ME WITH REGARDS TO THE PROCEDURE BUT THE TREATMENT AFTER THE PROCEDURE. HE JUST DOES NOT CARE ABOUT HIS PATIENTS... THE PHOTOGRAPHS OF MY BEFORE AND AFTER PICTURES DON'T SHOW ANYTHING, NOR DO THEY PROVE ANYTHING, WITH RESPECT TO THE PHYSICAL EVIDENCE OF MY ACTUAL BODY AND VISUAL PERCEPTION IN REALITY. WHEN YOU USE YOUR HAND TO PUSH UP SKIN, -AS THE PHOTOS INDICATE I DID-, IT DISTORTS THE AREA AND COLORATION, LIGHTING AND PRINTING CAN ALSO EFFECT PHOTOGRAPHS. THIS PRODUCT CAUSED ME PERMANENT PHYSICAL, EMOTIONAL, SOCIAL, AND PSYCHOLOGICAL DAMAGE. DATES OF USE: (B) (6) 2009-(B) (6) 2010. EVENT ABATED AFTER USE: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAXEL RESTORE LASER FRAXEL RESTORE LASER GEX SOLTA MEDICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention THIS WAS USED ON ME ON (B) (6) 2009 AND IT HAS| BEEN 9 MONTHS.