BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIMELIGHT

    MDR report key: 2214080 · Received July 19, 2011

    Report

    Report Number
    2954354-2011-00011
    Event Type
    Other
    Date Received
    July 19, 2011
    Date of Event
    November 3, 2010
    Report Date
    July 19, 2011
    Manufacturer
    CUTERA
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS SKIN TYPED BY THE TREATMENT PROVIDER AS BETWEEN SKIN TYPE IV - V. LIMELIGHT GUIDELINES ARE FOR SKIN TYPE I - IV. THE PATIENT REPORTS THAT THE DERMATOLOGIST TREATING THE HYPERPIGMENTATION SKIN TYPED HER AS "SKIN TYPE V". PATIENT REPORTS SHE DEVELOPED HYPERPIGMENTATION "THAT GOES AWAY WITH USE OF HYDROQUINONE". PATIENT STATED THAT HYPERPIGMENTATION COMES BACK AS SOON AS THE HYDROQUINONE IS STOPPED". THE ADVERSE EVENT DEVELOPED (B)(6) 2010, BUT WAS NOT REPORTED TO CUTERA UNTIL (B)(6) 2011. THE ADVERSE EVENT WAS NOT EVALUATED BY THE TREATMENT PROVIDER. THE LIMELIGHT HANDPIECE WAS EVALUATED (B)(6) 2011 AND FOUND TO BE OPERATING WITHIN SPECIFICATION. THE TREATMENT PROVIDER IS STILL IN POSSESSION OF THIS HANDPIECE.

    Description of Event or Problem · 1

    (B)(6) 2011: THIS WRITER RECEIVED TELEPHONE NOTIFICATION FROM PATIENT THAT SHE RECEIVED LIMELIGHT TREATMENT (B)(6) 2010, FOR PIGMENT. PATIENT HAS "8 BAR MARKS OF HYPERPIGMENTATION, 4 BAR MARKS ON RIGHT CHEEK, 4 BAR MARKS ON LEFT CHEEK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIMELIGHT LIMELIGHT GEX CUTERA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention