BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULITE ULTRA

    MDR report key: 4210674 · Received October 29, 2014

    Report

    Report Number
    2024312-2014-00654
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 2, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K082671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR SCOOPED OUT AND DRILLED OUT THE REMAINDER COMPOSITE. THE DOCTOR COMPLETED THE PROCEDURE USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT ALLEGED IN THIS INCIDENT WAS NOT RETURNED; THEREFORE, A 'DEPTH OF CURE' AND 'CURING TEST PER TIP' TESTS WERE PERFORMED, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS WITHIN THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE HERCULITE ULTRA COMPOSITE DID NOT FULLY POLYMERIZE DURING A PATIENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692847 HERCULITE ULTRA MATERIAL, TOOTH SHADE, RESIN EBF KERR CORPORATION 5184294

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other| R