BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMISE COMPOSITE

    MDR report key: 4726503 · Received April 24, 2015

    Report

    Report Number
    2024312-2015-00025
    Event Type
    Injury
    Date Received
    April 24, 2015
    Report Date
    March 25, 2015
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K032921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC INCIDENT WITH REGARD TO PATIENT AGE, WEIGHT AND GENDER WAS NOT PROVIDED. ALTHOUGH THE DOCTOR IDENTIFIED THREE (3) DIFFERENT SHADES ASSOCIATED WITH THE SHADE DISCREPANCY, THE DOCTOR COULD NOT VERIFY WHICH LOT WAS USED ON EACH PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENTS INCLUDE LOT NUMBERS 4961963, 5143048 AND 5233636. IT WAS REPORTED THAT THE DOCTOR REPLACED THE RESTORATION FOR THE PATIENT. TO DATE, THE PATIENT IS DOING FINE. A COLOR TEST WAS PERFORMED ON THE RETURN PRODUCTS 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 REGARD TO THESE LOTS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE SHADE FOR PREMISE COMPOSITE APPEARED TRANSLUCENT AFTER PLACEMENT FOR THREE (3) PATIENTS. THIS IS THE THIRD OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271664 PREMISE COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R