BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMI PLUS

    MDR report key: 3778070 · Received April 29, 2014

    Report

    Report Number
    2024312-2014-00272
    Event Type
    Injury
    Date Received
    April 29, 2014
    Report Date
    April 1, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBZ
    PMA / PMN Number
    K071251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO AGE, GENDER AND WEIGHT WAS NOT PROVIDED BY THE OFFICE. THE DOCTOR RE-CURED THE RESTORATION USING A DIFFERENT LIGHT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT FOUR (4) PATIENTS HAD EXPERIENCED SENSITIVITY AFTER LIGHT CURING THE COMPOSITE WITH DEMI PLUS. THIS IS THE SECOND OF FOUR (4) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257768 DEMI PLUS ULTRAVIOLET ACTIVATOR FOR POLYMERIZATION EBZ KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R