BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIA LASER HAIR REMOVAL SYSTEM

    MDR report key: 4112866 · Received September 17, 2014

    Report

    Report Number
    3005572989-2014-00002
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    June 2, 2014
    Report Date
    September 17, 2014
    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

    PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE DEVICE LABELING INDICATED THE PRODUCT IS NOT TO BE USED ON A MAN'S FACE. JAW OR NECK; THEREFORE, DEVICE WAS USED OFF-LABEL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PERSISTENT AREAS OF UNEVEN TEXTURE AND ERYTHEMA ON BOTH CORNERS OF LIPS AFTER TREATMENT WITH THE TRIA HAIR REMOVAL LASER. CUSTOMER USED OTC TOPICAL ON THE AFFECTED AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577052 TRIA LASER HAIR REMOVAL SYSTEM HAIR REMOVAL LASER GEX TRIA BEAUTY GEN 4X NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability