BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZOOM WHITENING LAMP AND PROCEDURE KIT

    MDR report key: 2389914 · Received October 28, 2011

    Report

    Report Number
    2032714-2011-00009
    Event Type
    Other
    Date Received
    October 28, 2011
    Date of Event
    September 29, 2011
    Report Date
    October 28, 2011
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED AND THE LIGHT OUTPUT FOR THE LAMP USED IN THE PROCEDURE WAS WITHIN MFG SPECIFICATIONS AT TIME OF SHIPMENT. IN ADDITION, A RETAIN SAMPLE OF THE WHITENING GEL USED IN THE PROCEDURE WAS ASSAYED AND WAS FOUND TO BE WITHIN ALL MFG SPECIFICATIONS.

    Description of Event or Problem · 1

    AFTER THE THIRD (3 OF 4) SESSIONS OF THE CHAIR SIDE WHITENING TREATMENT, THE PT COMPLAINED OF A LOT OF TOOTH SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM WHITENING LAMP AND PROCEDURE KIT EEG DISCUS DENTAL, LLC ZM2613 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other STRENGTH AND FREQUENCY NOT KNOWN.| LOT# 11105021, EXPIR DATE: 10/13/2011, NDC# (B)(4)| ZOOM AP LAMP AND ZOOM WHITENING PROCEDURE KIT 25%:| THE DENTIST PRESCRIBED BICODYN TO THE PT.