BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO NO PRO

    MDR report key: 5829946 · Received July 25, 2016

    Report

    Report Number
    MW5063703
    Event Type
    Injury
    Date Received
    July 25, 2016
    Date of Event
    July 25, 2016
    Report Date
    July 25, 2016
    Manufacturer
    RADIANCY INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY MOTHER BOUGHT THE NO!NO! HAIR REMOVAL ITEM FOR ME AND IT WAS ONE OF THE WORST AND HUMILIATING EXPERIENCES OF MY LIFE. I REALLY WANTED THIS PRODUCT TO WORK, BUT THIS PRODUCT SHOULD BE TAKEN OFF THE SHELVES AS WELL AS THE OTHER "AS SEEN ON TV" ITEMS. THIS PRODUCT HAS 2 DIFFERENT SIZES OF THE "TECHNOLOGY" THAT'S SUPPOSED TO REMOVE HAIR; A "WIDE TIP" FOR THE LEGS ARMS AND OTHER LARGE BODY PARTS AND A "NARROW TIP" FOR THE LIP AREA. AFTER A FEW HOURS OF PROPERLY USING THE ITEM I DEVELOPED BLOTCHY BLISTERS ON MY FACE THAT ARE EXTREMELY PAINFUL AND ARE ONLY GETTING WORSE AS THE DAY GOES ON. THEY ALSO PROVIDED A TUBE OF WHAT APPEARED TO BE CHAP STICK THAT IS SUPPOSED TO PREVENT DAMAGE TO THE SKIN ON THE LIPS, BUT MY LIPS HAVE BLISTERS ANYWAY. THE BLISTERS ARE IRRITATED BY LIGHT SO GOING OUTSIDE IS NOT ONLY PAINFUL, BUT ALSO EMBARRASSING. WITH THAT BEING SAID, I AM PROBABLY GOING TO MISS A REQUIRED LAB FOR MY UNIVERSITY EDUCATION BECAUSE OF THIS FAULTY PRODUCT. PLEASE TAKE THIS SERIOUSLY TO PREVENT OTHER PEOPLE FROM GETTING HURT. ROUTE: APPLIED TO A SURFACE, USUALLY THE SKIN. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473432 NO NO PRO NO NO PRO GEX RADIANCY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR