BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIA LASER HAIR REMOVAL SYSTEM

    MDR report key: 3975831 · Received July 7, 2014

    Report

    Report Number
    3005572989-2014-00001
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    February 10, 2014
    Report Date
    July 7, 2014
    Manufacturer
    TRIA BEAUTY
    Product Code
    GEX
    PMA / PMN Number
    K090820
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 IN THE GENITAL AREA; THEREFORE THIS WAS OFF-LABEL USED.

    Description of Event or Problem · 1

    TRIA BEAUTY, INC WAS NOTIFIED THAT A CUSTOMER DEVELOPED SKIN BLISTER IN THE GENERAL AREA AFTER USING THE HAIR REMOVAL LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394778 TRIA LASER HAIR REMOVAL SYSTEM HAIR REMOVAL LASER GEX TRIA BEAUTY GEN 4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention