BEUDAMED
    FDA Adverse Event Other Summary report: N

    WHITE LIGHT

    MDR report key: 749012 · Received September 14, 2005

    Report

    Report Number
    MW1036628
    Event Type
    Other
    Date Received
    September 14, 2005
    Date of Event
    August 9, 2005
    Report Date
    September 14, 2005
    Manufacturer
    WHITE LIGHT
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED TWO -2- KITS OF WHITE LIGHT. I USED WHITE LIGHT AS PRESCRIBED. THE VERY NEXT MORNING, HAVING HAD AN ADVERSE REACTION I DISCONTINUED USE OF THE PRODUCT. THE ADVERSE REACTION FROM WHITE LIGHT WAS THE CORNERS OF MY MOUTH WERE SWOLLEN, CHAFFED, SORE, BURNING AND CRUSTY. AT 2:45PM OUR TIME, I CALLED WHITE LIGHT AND I SPOKE WITH CUSTOMER SERVICE REPRESENTATIVE. I EXPLAINED MY COMPLAINT AND REP ADVISED ME THAT MY SHIPPING CHARGE WOULD NOT BE REFUNDED AND I WOULD HAVE TO PAY ADDITIONAL SHIPPING CHARGES TO RETURN THE WHITE LIGHT PRODUCTS, THEREFORE, I AM TURNING THIS MATTER OVER TO AN ATTORNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHITE LIGHT TEETH WHITENING SYSTEM EEG WHITE LIGHT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other COLGATE TOOTHPASTE| BIRTH CONTROL PILLS| LISTE RINSE| PRO HEALTH RINSE BY CREST| PEPSODENT TOOTHPASTE| VITAMIN E| FERROUS GLUCONATE