BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEMI

    MDR report key: 4240847 · Received November 10, 2014

    Report

    Report Number
    2024312-2014-00659
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 24, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBZ
    PMA / PMN Number
    K071251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED SENSITIVITY. UPON THE PATIENT'S RETURN VISIT, THE DOCTOR NOTICED THAT THE COMPOSITE WAS NOT COMPLETELY CURED. THE DOCTOR REMOVED THE RESTORATION AND REPLACED IT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE DEMI LIGHT WAS NOT RETURNED; THEREFORE, NO EVALUATIONS CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT THE DEMI LIGHT WAS NOT CURING RESTORATIONS FOR TWO (2) PATIENTS. THIS IS THE FIRST OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722706 DEMI ACTIVATOR,ULTRAVIOLET,FORPOLYMERIZATION EBZ KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other