BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKIN PERFECTING BLUE LIGHT DEVICE

    MDR report key: 3122196 · Received May 17, 2013

    Report

    Report Number
    3005572989-2013-00001
    Event Type
    Injury
    Date Received
    May 17, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 16, 2013
    Manufacturer
    TRIA BEAUTY, INC.
    Product Code
    GEX
    PMA / PMN Number
    K090312
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION. WILL CONTINUE TO MONITOR CUSTOMER STATUS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED USING THE TRIA BLUE LIGHT ACNE DEVICE TO "SPOT TREAT" A PROBLEM AREA AND SUBSEQUENTLY DEVELOPED A "DARKENED SKIN AREA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218807 SKIN PERFECTING BLUE LIGHT DEVICE GEX TRIA BEAUTY, INC. SPBL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other