BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROFILE

    MDR report key: 1615601 · Received February 16, 2010

    Report

    Report Number
    2953696-2010-00004
    Event Type
    Other
    Date Received
    February 16, 2010
    Date of Event
    June 27, 2008
    Report Date
    June 30, 2008
    Manufacturer
    SCITON, INC.
    Product Code
    GEX
    PMA / PMN Number
    070388
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE REPORTED EVENT BY SCITON CLINICAL STAFF CONCLUDED THAT THE PROBABLE ROOT CAUSE WAS TREATING A PT WHO WAS AN "AVID TANNER." THE PARAMETERS OF THE PROTOCOL WERE REINFORCED WITH THE CLINICIAN WITH PARTICULAR ATTENTION GIVEN TO THE PT'S SKIN TYPE AND TANNED SKIN AS A CONTRAINDICATION WHEN RECEIVING BBL TREATMENT. THE FUNCTION OF BBL DEVICE IS NOT IN QUESTION.

    Description of Event or Problem · 1

    A CLINICIAN TREATING A PT FOR BROWN SPOTS ON FOREARM REPORTED THAT THE PT PRESENTED IN THE OFFICE WITH RED-BROWN EPIDERMAL CRYSTAL SHAPED AREAS ON BOTH FOREARMS AND SOME APPEARANCE OF BLISTERING. THE PT IS REPORTED TO BE AN "AVID TANNER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFILE BBL GEX SCITON, INC. PROFILE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA