BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENLIGHTEN

    MDR report key: 6980199 · Received October 26, 2017

    Report

    Report Number
    2954354-2017-00004
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    September 23, 2017
    Report Date
    October 10, 2017
    Manufacturer
    CUTERA, INC
    Product Code
    GEX
    PMA / PMN Number
    K140727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LASER TATTOO REMOVAL TREATMENT # 3 TO RIGHT FOREARM AND LEFT WRIST MULTICOLORED TATTOO WITH THE 1064 NM AND 532 NM WAVELENGTHS ON THE ENLIGHTEN LASER SYSTEM. ACCORDING TO DOCUMENTATION RECEIVED IN THE COURSE OF OUR INVESTIGATION, IT APPEARS THAT THE SETTINGS USED TO PERFORM THE TREATMENT WERE INCONSISTENT WITH THE RECOMMENDED TREATMENT SETTINGS FOR BOTH THE 1064 NM AND THE 532 NM WAVELENGTHS. THE TREATED AREAS DEVELOPED PARTIAL THICKNESS BURNS THAT DID NOT REQUIRE PROFESSIONAL WOUND MANAGEMENT. BECAUSE THE PHYSICIAN HAS NOT ALLOWED CUTERA FIELD SERVICE REPRESENTATIVES TO INSPECT AND TEST THE LASER FOR REASONS THE PHYSICIAN DESCRIBES AS A HIGH LIKELIHOOD OF LITIGATION, CUTERA HAS BEEN UNABLE TO DETERMINE IF THE DEVICE PERFORMED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760290 ENLIGHTEN ENLIGHTEN LASER SYSTEM, PRODUCT CODE:GEX GEX CUTERA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other