BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIA LASER HAIR REMOVAL SYSTEM

    MDR report key: 3377723 · Received September 25, 2013

    Report

    Report Number
    3005572989-2013-00002
    Event Type
    Injury
    Date Received
    September 25, 2013
    Date of Event
    June 1, 2013
    Report Date
    September 24, 2013
    Manufacturer
    TRIA BEAUTY
    Product Code
    GEX
    PMA / PMN Number
    K090820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS ADVISED THAT DEVICE LABELING INDICATED THE DEVICE IS NOT TO BE USED ON THE MALE FACIAL AREA DUE TO GREATER HAIR DENSITY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DEVELOPING A BLISTERING SKIN REACTION, FOLLOWED BY PERSISTENT AREAS OF UNEVEN TEXTURE AND ERYTHEMA ON THE CHEEK AFTER TREATMENT WITH THE TRIA HAIR REMOVAL LASER. CUSTOMER USED 1% SILVADENE CREME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483773 TRIA LASER HAIR REMOVAL SYSTEM HAIR REMOVAL LASER GEX TRIA BEAUTY GEN4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other