BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZOOM NITEWHITE 16%

    MDR report key: 2818422 · Received October 5, 2012

    Report

    Report Number
    2032714-2012-00003
    Event Type
    Other
    Date Received
    October 5, 2012
    Date of Event
    September 11, 2012
    Report Date
    October 5, 2012
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DFU WAS REVIEWED FOR WARNINGS AND CAUTIONS. IT DOES STATE HOW TO FILL THE TRAYS (TO AVOID OVERFILLING). IT ALSO NOTES THAT IT IS HARMFUL IF SWALLOWED.

    Description of Event or Problem · 1

    PATIENT COMPLAINED THAT AFTER 3 APPLICATIONS (USES) OF THE TAKE HOME , WHITENING GEL CAUSED SWELLING AND IRRITATION IN HER THROAT. HER DENTIST ADVISED THAT SHE SEEK HER PCP (PERSONAL CARE PHYSICIAN). PATIENT DID VISIT HER DOCTOR AND THEY WERE UNABLE TO FIND A REASON FOR THE SWELLING AND IRRITATION. THE PATIENT HAS DISCONTINUED USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM NITEWHITE 16% NONE EEG DISCUS DENTAL, LLC ZNW1006 12128020

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other