BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIMELIGHT

    MDR report key: 1982696 · Received February 3, 2011

    Report

    Report Number
    2954354-2011-00003
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    May 7, 2009
    Report Date
    February 2, 2011
    Manufacturer
    CUTERA
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT RECEIVED A BURN, ALTHOUGH THE EXTENT OF THE BURN IS NOT CLEAR. THE DOCTOR DOES INDICATE IN AN EMAIL THAT THE PT WAS SCARRED. THE HANDPIECE WAS OUT OF SPECIFICATION ON ALL SETTINGS. NO CLEAR ROOT CAUSE WAS DETERMINED WHEN EVALUATED BY CUTERA.

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED LIMELIGHT TREATMENT TO UPPER BACK, SHOULDERS, CHEST AND FACE. PT WAS DIAGNOSED WITH "FIRST AND SECOND DEGREE BURNS" RESULTING IS "SCARS". THE LIMELIGHT HANDPIECE WAS OUT OF SPECIFICATION. DOSE, FREQUENCY AND ROUTE USED: B - 16-18J TRANSDERMAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention