BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEMI PLUS

    MDR report key: 2150015 · Received July 5, 2011

    Report

    Report Number
    3003848022-2011-00012
    Event Type
    Injury
    Date Received
    July 5, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 8, 2011
    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

    THE DEMI OPERATING MANUAL LISTS THREE (3) CURING CYCLES: FIVE (5) SECONDS, TEN (10) SECONDS AND TWENTY (20) SECONDS. THE DEMI IS A HIGH-OUTPUT CURING UNIT WITH RECOMMENDED CURING TIMES FOR UNIVERSAL COMPOSITES, BONDING AGENTS AND CEMENTS OF FIVE (5) OR TEN (10) SECONDS. IN THESE INCIDENTS THE DOCTOR CONFIRMED THAT HE CURED THE RESIN COMPOSITE MATERIALS FOR TWENTY (20) SECONDS FOLLOWED BY ANOTHER TWENTY (20) SECOND CURE FOR A TOTAL OF FORTY (40) SECONDS. THIS EXCEEDS THE CURING TIME RECOMMENDATIONS LISTED IN THE OPERATING MANUAL WHICH STATES THAT THE UNIT SHOULD BE USED FOR A DUTY CYCLE OF TWENTY (20) SECONDS ON AND ONE (1) MINUTE OFF.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011, DOCTOR ALLEGED THAT THE DEMI PLUS UNIT GETS TOO HOT. DOCTOR WAS ACTUAL PATIENT AND HE NOTICED IT. DOCTOR ALLEGED THAT FIFTEEN (15) PATIENTS HAVE HAD TO HAVE ROOT CANAL THERAPY FOR NERVE DAMAGE CAUSED BY THE UNIT'S EXTREME HEAT. AS OF (B)(6) 2011, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE ALLEGATIONS COULD NOT BE CONFIRMED. DEVICE NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6) 2011, KERR CORPORATION RECEIVED NOTIFICATION THAT A DOCTOR ALLEGEDLY HAD FIFTEEN (15) PATIENTS WHO HAD TO HAVE ROOT CANAL THERAPY DUE TO NERVE DAMAGE CAUSED BY THE DEMIPLUS UNIT GETTING TOO HOT. THIS IS THE TWELFTH OF FIFTEEN (15) REPORTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R