BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENLIGHTEN III

    MDR report key: 19685604 · Received July 6, 2024

    Report

    Report Number
    2954354-2024-00012
    Event Type
    Injury
    Date Received
    July 6, 2024
    Date of Event
    June 6, 2024
    Report Date
    August 7, 2024
    Manufacturer
    CUTERA, INC.
    Product Code
    GEX
    PMA / PMN Number
    K182997
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    INITIAL REPORT: THE ENLIGHTEN III 1064 NM LASER WAS USED TO TREAT THE PATIENT'S FACE. THE TREATED AREA DEVELOPED ITCHINESS AND SCABS RESULTING IN PATCHY AREAS OF EPIDERMAL PIGMENT LOSS (HYPOPIGMENTATION). **ADDITIONAL INFORMATION THAT WAS NOT AVAILABLE AT THE TIME OF THE INITIAL REPORT HAS BEEN ADDED BELOW, BASED ON FINDINGS FROM THE INVESTIGATION,** FIELD SERVICE EVALUATION: THE LASER SYSTEM WAS EVALUATED BY CUTERA SERVICE AND MEETS ALL PERFORMANCE SPECIFICATIONS. IN ADDITION, THERE WERE NO ERROR CODES LOGGED ON THE TREATMENT DATE. PATIENT FOLLOW-UP: THE CLINIC HAS REPORTED SIGNIFICANT IMPROVEMENT IN THE COLOR CONTRAST OF THE SKIN. THE CLINIC AND PATIENT HAVE DECIDED TO WAIT UNTIL THE FALL TO COMPLETE THE PICO GENESIS PROCEDURES. WE EXPECT THE SKIN COLOR MISMATCH TO CONTINUE IMPROVING OVER TIME. ROOT CAUSE DETERMINATION: ALTHOUGH THE CLINIC AND PATIENT DID NOT SPECIFICALLY MENTION SUN EXPOSURE AS THE REASON FOR THE HYPOPIGMENTATION, CUTERA BELIEVES THIS IS THE MOST LIKELY CAUSE.

    Description of Event or Problem · 0

    THE ENLIGHTEN III 1064 NM LASER WAS USED TO TREAT THE PATIENT'S FACE. THE TREATED AREA DEVELOPED ITCHINESS AND SCABS RESULTING IN PATCHY AREAS OF EPIDERMAL PIGMENT LOSS (HYPOPIGMENTATION). THE LASER SYSTEM IS PENDING EVALUATION BY CUTERA SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434300 ENLIGHTEN III DERMATOLOGY LASER GEX CUTERA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male Other