BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULITE XRV

    MDR report key: 3881409 · Received June 18, 2014

    Report

    Report Number
    2024312-2014-00430
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 20, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K943642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE DOCTOR IDENTIFIED TWO (2) DIFFERENT LOTS ASSOCIATED WITH THE VOIDS, HE COULD NOT VERIFY WHICH LOT WAS USED THE PATIENT; THEREFORE NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 4951195 AND 5005137. THE DOCTOR CUT OUT THE COMPOSITE FOR TOOTH #3 AND REFILLED THE PREP USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS ALLEGED IN THIS INCIDENT WERE NOT RETURNED; THEREFORE, A VOID TEST WAS PERFORMED ON THE RETAIN SAMPLES FOR LOT NUMBERS 4951195 AND 5005137, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW REVEALED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARDS TO THESE LOTS.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT VOIDS AND OPEN MARGINS APPEARED ON X-RAYS AFTER PLACEMENT OF THE HERCULITE XRV COMPOSITE FOR TWO (2) PATIENTS. THIS IS THE SECOND OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357703 HERCULITE XRV MATERIAL, TOOTH SHADE, RESIN EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other| R