BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM WHITENING GEL

    MDR report key: 1190225 · Received October 6, 2008

    Report

    Report Number
    MW5008564
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    October 4, 2008
    Report Date
    October 6, 2008
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD ZOOM WHITENING DONE ON MY TEETH BY DA VINCI TEETH WHITENING SYSTEMS AND THE NEXT DAY, MY GUMS WERE BLEEDING AND SWOLLEN. MY LIPS WERE SWOLLEN. I HAVE NOT BEEN IN SUCH PAIN BEFORE. I WENT TO THE DENTIST, AND HE SAID IT WAS NOT APPLIED RIGHT. I HAVE NOT BEEN ABLE TO EAT OR SLEEP BECAUSE OF THE THROBBING PAIN, AND I CAN'T EVEN BRUSH MY TEETH BECAUSE IT'S LIKE USING A WIRE BRUSH. YOU MIGHT CONSIDER YOU ARE LETTING THEM APPLY THIS WHITENING GEL AND IF ITS BEING DONE RIGHT, AND BY PEOPLE WHO KNOW WHAT THEY ARE DOING. THEIR FLYER SAID THEY WERE FDA APPROVED; YOU MIGHT RETHINK THIS. THANK YOU FOR YOUR TIME, FREQUENCY: 15 MINS; ROUTE: TOP. DATES OF USE: 2008, 15 MINS. DIAGNOSIS OR REASON FOR USE: TEETH WHITENER. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: #1 AND #2: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM WHITENING GEL NONE EEG

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other