BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZOOM WHITENNG LAMP AND PROCEDURE KIT

    MDR report key: 2932455 · Received November 2, 2012

    Report

    Report Number
    2032714-2012-00004
    Event Type
    Other
    Date Received
    November 2, 2012
    Date of Event
    October 4, 2012
    Report Date
    November 2, 2012
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    A RETAIN SAMPLE OF THE WHITENING GEL (SAME PART/LOT NUMBER) USED IN THE PROCEDURE WAS ASSAYED AND FOUND TO BE WITHIN ALL MANUFACTURING SPECIFICATIONS FOR PH AND PEROXIDE CONCENTRATION. IN ADDITION, THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE UV LIGHT LAMP HEAD AND THE LIGHT OUTPUT TESTING FOR THE LAMP HEAD SERIAL NUMBER USED IN THE PROCEDURE WAS WITHIN MANUFACTURING SPECIFICATIONS AT TIME OF SHIPMENT.

    Description of Event or Problem · 1

    PATIENT DEVELOPED AN ALLERGIC REACTION DURING A CHAIR SIDE WHITENING PROCEDURE. PATIENT'S LIPS WERE SWOLLEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM WHITENNG LAMP AND PROCEDURE KIT GEX DISCUS DENTAL, LLC ZM2604P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other