BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIMELIGHT

    MDR report key: 2223900 · Received August 18, 2011

    Report

    Report Number
    2954354-2011-00013
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    June 20, 2011
    Report Date
    August 17, 2011
    Manufacturer
    CUTERA
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011: PT REPORTED ADVERSE EVENT. THIS WRITER REQUESTED NAME OF CLINIC AND ADVERSE EVENT INFO. THE PT STATED SHE HAD A "LIMELIGHT" TREATMENT. THE DEVICE IS NOT AVAILABLE FOR INSPECTION, DEVICE OWNER AND LOCATION IS UNK. ON (B)(6) 2011: PT RESPONDED BY EMAIL TO REQUEST #3 FOR ADVERSE EVENT INFO. THE PT ONLY PROVIDED PICTURES AND STATED THAT SHE HAS "SCARS" ON HER "NECK" AND "CURRENTLY RECEIVING TREATMENT FOR THIS." CUTERA IS UNABLE TO EVALUATE THE DEVICE AT THIS TIME DUE TO THE SERIAL NUMBER, DEVICE OWNER AND LOCATION IS UNK. CUTERA HAS REQUESTED THIS INFO FOUR TIMES FROM THE PT THAT REPORTED THE ADVERSE EVENT. CUTERA HAS REQUESTED THE TREATMENT, MEDICAL AND ADVERSE EVENT INFO 4 TIMES FROM THE PT. THIS INFO IS INCOMPLETE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2011: CUTERA REC'D THE FOLLOWING INFO BY EMAIL FROM A PT THAT WAS TREATED AT AN UNK LOCATION. "I RECENTLY HAD LIMELIGHT THERAPY FROM MY THERAPIST WHO HAS BEEN TREATING ME FOR 2.5 YRS. SHE DID LIMELIGHT ON ME AND I AM BRUISED, BLISTERED, BURNT, SWOLLEN AND HAVE HAD TO TAKE A WEEK OFF WORK. SHE DID IT ON A LOW SETTING (B SETTING) AND HAS DONE GENESIS AND PEELS ON ME IN THE PAST."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention