BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL RESTORE

    MDR report key: 11929723 · Received June 2, 2021

    Report

    Report Number
    MW5101672
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    February 3, 2021
    Report Date
    May 29, 2021
    Manufacturer
    SOLTA MEDICAL, INC.
    Product Code
    ONG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FACE DEFORMITIES; HAD A FRAXEL RESTORE TREATMENT AT A DOCTOR'S OFFICE. NO PROPER CONSULTATION GIVEN. WASN'T GIVEN A MEDICAL BACKGROUND CHECK, NO QUESTIONS WERE ASKED, NO AREAS OF CONCERN ENQUIRED ABOUT. DIDN'T EVEN EXAMINE MY FACE. I HAD NO ACNE, SMALL WRINKLING AROUND THE EYES NOTHING MAJOR, VERY LITTLE PIGMENTATION. STILL WAS GIVEN A FULL FACE FRAXEL ON A SETTING THAT MELTED MY FACE AND 3 MONTHS LATER IS STILL COMPLETELY RAW. LITTLE TO NO AFTERCARE WAS GIVEN, AND I ENDED UP WITH AN INFECTION. WHEN I RETURNED TO THE CLINIC THEY SAID "NOTHING WAS WRONG" I HAD TO ATTEND ANOTHER DERMATOLOGIST. I HAVE NOW REALIZED AFTER MUCH RESEARCH, THAT THESE LIFE ALTERING EFFECTS ARE HABITUAL, YET ARE STILL MARKETED AND GIVEN TO PEOPLE WHO DO NOT NEED THEM. I HAD NO IDEA OF THE EXTENT OF THE DAMAGE THESE DEVICES CAUSE, ALTHOUGH THE DOCTORS DO. I AM NOW SEVERELY DEPRESSED AND ON ANTI DEPRESSION MEDICATION. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822863 FRAXEL RESTORE POWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT ONG SOLTA MEDICAL, INC. DON'T KNOW DON'T KNOW

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other