BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRITE SMILE

    MDR report key: 280474 · Received June 6, 2000

    Report

    Report Number
    MW1019064
    Event Type
    Other
    Date Received
    June 6, 2000
    Date of Event
    June 1, 2000
    Report Date
    June 6, 2000
    Manufacturer
    BRITE SMILE , INC
    Product Code
    EEG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO REPORTER, DEVICE IS USED FOR A ONE HOUR TREATMENT FOR WHITENING TEETH AND IN A HIGH NUMBER OF CASES THIS DEVICE CAUSES ULCERS OF THE LIPS. REPORTER IS CONCERNED THAT THOSE PTS WHO ARE IMMUNOCOMPROMISED, SUCH AS THEIR SPOUSE IN THIS CASE AND THE GENERAL HEALTHY PUBLIC IN OTHER CASES THEY ARE AWARE OF, ARE AT RISK OF SOFT TISSUE BURNS. THERE IS NO DISCLAIMER ON THE DEVICE. THE MACHINE IS LEASED FROM CO TO PROFESSIONAL DENTAL OFFICES. HOWEVER, PROFESSIONALS ARE NOT THE ONLY ONES USING IT. AN ASSISTANT CAN BE TRAINED IN A ONE DAY SEMINAR. REPORTER SPOKE TO CO AND WAS TOLD THEY HAD NO STUDIES ON ITS USE. REPORTER IS CONCERNED THAT THERE MIGHT HAVE BEEN NO CONSIDERATION OF THE EFFECTS OF THE LIGHT ON SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRITE SMILE BLUE LIGHT THERAPY FOR BLEACHING TEETH EEG BRITE SMILE , INC UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other