BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRITE SMILE LASER

    MDR report key: 307248 · Received November 27, 2000

    Report

    Report Number
    MW1020520
    Event Type
    Injury
    Date Received
    November 27, 2000
    Date of Event
    November 21, 2000
    Report Date
    November 27, 2000
    Manufacturer
    UNK
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BRITESMILE LASER CREATED A LONG BURN ON LOWER LIP. THE LASER TREATMENT WAS PERFORMED IN A DENTAL OFFICE BY A TECH. THE BURN WAS OBVIOUS 4-6 HRS LATER AND LEAD TO SIGNIFICANT PAIN AND IMPAIRMENT OF MOUTH. SIX DAYS LATER RPTR STILL HAS ULCERATIONS. RPTR HAD AT LEAST 3 FULL SLOUGHS OF THE BURNED AREA. RPTR WAS SEEN AT THEIR REQUEST, BY THE DENTIST THE DAY AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRITE SMILE LASER MEDICAL LASER GEX UNK UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability