BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMA ARCH

    MDR report key: 548006 · Received July 6, 2004

    Report

    Report Number
    MW1032557
    Event Type
    Injury
    Date Received
    July 6, 2004
    Date of Event
    May 26, 2004
    Report Date
    July 6, 2004
    Manufacturer
    LUMALITE, INC.
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DENTAL WHITENING PROCEDURE USING LUMA ARCH -K002566 OR SIMILAR- WAS EXCRUCIATINGLY PAINFUL DURING APPLICATION OF BLEACHING AGENT PLUS HEAT FROM LIGHT SOURCE. PROTECTIVE COATING APPLIED TO GUMS GAVE INSUFFICIENT PROTECTION AND BLEACHING AGENT CAUSED BURNS -OR "BLANCHING"- OF MULTIPLE SECTIONS OF GUMS. BURN AREAS PERSISTED FOR 1-3 WEEKS AND ONE RESULTED IN 2-3 MM HOLE IN GUM THROUGH TO EXPOSED JAW BONE. AS OF 41 DAYS LATER GUM HAS FAILED TO HEAL AND IF IT DOES NOT HEAL A TISSUE GRAFT MAY BE NEEDED TO COVER THE HOLE AND PREVENT EXPOSURE/INFECTION OF THE BONE. PRIOR TO BLEACHING, TEETH INVOLVED WERE ETCHED WITH AN ACID OR SIMILAR AGENT. THIS LEFT TEETH ROUGHER ON SURFACE AND MORE SUSCEPTIBLE TO ACCUMULATION OF PLAQUE. CO LITERATURE DID NOT DESCRIBE THESE POTENTIAL ADVERSE EFFECTS OF THE BLEACHING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMA ARCH DENTAL WHITENING PROCESS EEG LUMALITE, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R LUMA ARCH LIGHT SOURCE, BLEACHING AGENT, GUM| PROTECTIVE COATING.