BEUDAMED
    FDA Adverse Event Other Summary report: N

    NITE WHITE EXCEL

    MDR report key: 411767 · Received July 9, 2002

    Report

    Report Number
    MW4003316
    Event Type
    Other
    Date Received
    July 9, 2002
    Date of Event
    March 24, 2002
    Report Date
    July 9, 2002
    Manufacturer
    DISCUS DENTAL INC
    Product Code
    EEG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT RECEIVED INFO (FOIA REQUEST) FROM DISTRICT OFFICE ON COMPLAINTS REGARDING DISCUS DENTAL, WHICH HAS REGISTRATION FOR A CLASS II DEVICE. COMPLAINT IS THIS PRODUCT CAUSED PERMANENT DAMAGE TO TEETH, WHETHER THROUGH LACK OF INFO FROM DENTIST (WHO GAVE RPTR THE PRODUCT) AND/OR DUE TO THE PRODUCT ITSELF. THEY SAID THE RECEPTIONIST/DENTIST'S COWORKER INFORMED THEM THAT DISCUS DENTAL CALLED THE DENTAL OFFICE SEVERAL MOS AGO ASKING THE DENTAL OFFICE TO CHECK FOR ONE OF THEIR PRODUCTS WITH A CERTAIN LOT NUMBER. IF IT WAS FOUND, IT WAS TO BE RETURNED. THE COMPLAINANT NOW HAS ROOT EXPOSURE, WHICH CAUSES PAIN AND NEEDS ADD'L DENTAL WORK DUE TO THIS SITUATION. AT THE TIME COMPLAINANT USED THE PRODUCT, THEY DID NOT KNOW THE STRENGTH. IMMEDIATELY PRIOR TO THIS TREATMENT THEY HAD THEIR TEETH EXAMINED AND CLEANED BY THE DENTIST ("HEALTHY TEETH", THEY WERE TOLD) WHO GAVE THEM THE PRODUCT. THE COMPLAINANT SAID THEY NEVER RECEIVED ANY WRITTEN INSTRUCTIONS WITH THE PRODUCT. COMPLAINANT HAS HIRED A LAWYER AND WAS GOING TO CONTACT THE STATE DENTAL BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NITE WHITE EXCEL BLEACHER EEG DISCUS DENTAL INC NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other