BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIA LASER 4X

    MDR report key: 5396757 · Received January 21, 2016

    Report

    Report Number
    MW5059719
    Event Type
    Malfunction
    Date Received
    January 21, 2016
    Date of Event
    January 16, 2016
    Report Date
    January 21, 2016
    Manufacturer
    TRIA BEAUTY
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A TRIA LASER. THE PRODUCT WAS FAULTY FROM THE BEGINNING BY NOT TURNING ON OR ACTIVATING PROPERLY. THE COMPANY IS NOT CONCERNED WITH THE SAFETY OF ITS CONSUMERS. I AM WORRIED TO USE THE LASER, AND FEAR OTHERS COULD HAVE PROBLEMS WITH THEIR OWN LASERS AND TRIA IS DOING NOTHING TO HELP. THIS IS AN ITEM THAT HAS THE POTENTIAL TO HURT ITS USERS AND FAULTY PARTS ARE NEVER GOOD, BUT ESPECIALLY SO IF THE COMPANY WHO PRODUCES THEM IS NOT CONCERNED ABOUT HEALTH AND WELLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41328 TRIA LASER 4X TRIA LASER 4X GEX TRIA BEAUTY LHR 4.0

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR