BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICFILL COMPOSITE

    MDR report key: 3929462 · Received July 11, 2014

    Report

    Report Number
    2024312-2014-00495
    Event Type
    Injury
    Date Received
    July 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K091023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE AND WEIGHT WAS NOT PROVIDED. ALTHOUGH THE OFFICE IDENTIFIED THREE (3) DIFFERENT LOTS ASSOCIATED WITH THE BLACK SPECKS, THE OFFICE COULD NOT VERIFY WHICH LOT HAD BEEN USED ON THE PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENT INCLUDE LOT NUMBERS 4427237, 5077103, AND 4874476. THE DOCTOR DRILLED OUT THE COMPOSITE AND REPEATED THE PROCEDURE DURING THE SAME OFFICE VISIT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCTS INVOLVED IN THE ALLEGED INCIDENT WERE RETURNED AND A VISUAL EVALUATION WAS PERFORMED ON EACH OF THE LOTS, YIELDING RESULTS WITHIN SPECIFICATIONS. IN ADDITION, A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT BLACK SPECKS WERE PRESENT IN THE SONICFILL COMPOSITE DURING PROCEDURES ON TWO (2) PATIENTS. THIS IS THE SECOND OF TWO (2) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405952 SONICFILL COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R