BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOOM WHITENING LAMP AND PROCEDURE KIT

    MDR report key: 2159093 · Received July 5, 2011

    Report

    Report Number
    MW5021286
    Event Type
    Injury
    Date Received
    July 5, 2011
    Date of Event
    June 6, 2011
    Report Date
    July 5, 2011
    Manufacturer
    DISCUS DENTAL, LLC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    AFTER THE THIRD CYCLE OF A FOUR CYCLE PROCEDURE, THE PATIENT REPORTED, HE WAS FEELING "ZINGERS" (TOOTH SENSITIVITY), BUT WANTED TO COMPLETE THE LAST (4TH) CYCLE. AFTER THE 4TH CYCLE, HE CONTINUED TO HAVE SENSITIVITY ISSUES. DR (B)(6) PRESCRIBED VICODIN TO THE PATIENT. ONLY TREATMENT DATE WAS ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOOM WHITENING LAMP AND PROCEDURE KIT EEG EEG DISCUS DENTAL, LLC ZM2564

    Patients

    Seq Age Sex Outcome Treatment
    1 Other EXPIRATION DATE: 04/20/2012| ZOOM WHITENING PROCEDURE KIT 25%: LOT #10321018