BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENLIGHTEN

    MDR report key: 6978573 · Received October 25, 2017

    Report

    Report Number
    2954354-2017-00003
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    September 26, 2017
    Report Date
    September 29, 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 MULTICOLORED TATTOO WITH THE 1064 NM AND 532 NM WAVELENGTHS ON THE ENLIGHTEN DEVICE. 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. ULTIMATELY, THE TREATED AREA DEVELOPED PARTIAL THICKNESS BURNS THAT REQUIRED 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, WE HAVE BEEN UNABLE TO DETERMINE IF THE DEVICE PERFORMED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757327 ENLIGHTEN ENLIGHTEN LASER SYSTEM GEX CUTERA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention