BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMENIS ONE

    MDR report key: 1190223 · Received October 6, 2008

    Report

    Report Number
    MW5008562
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    June 21, 2008
    Report Date
    October 6, 2008
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD 4 IPL TREATMENTS WITH THE LUMENIS ONE MACHINE STARTING IN 2008, AND ENDING AT ABOUT 77 DAYS LATER. I HAVE SHALLOW INDENTATIONS-POSSIBLE FAT LOSS-, HOLES, SKIN TEXTURE CHANGES, LINES, AND OTHER MARKS ALL OVER MY FACE. I WAS TOLD MY SKIN LOOKED THE WAY IT DID BECAUSE MY PORES WERE "CLOGGED". THIS HAS DESTROYED MY LIFE. I'M SURE THE PERSON WHO DID THIS MUST HAVE HAD THE MACHINE TURNED UP TOO HIGH FOR MY SKIN TYPE, AND I WAS NEVER WARNED THAT THIS COULD HAPPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMENIS ONE LUMENIS ONE GEX

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention| S