BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICFILL COMPOSITE

    MDR report key: 3092428 · Received May 3, 2013

    Report

    Report Number
    2024312-2013-00197
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 10, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K091023
    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 SHADES ASSOCIATED WITH THE SENSITIVITY, SHE COULD NOT VERIFY WHICH LOT WAS USED ON WHICH EACH PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. SPECIFIC INFORMATION WITH REGARD TO PATIENT GENDER, AGE, WEIGHT, AND NUMBER AFFECTED WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR IS WAITING FOR A NEW CURING LIGHT TO BE RECEIVED TO RE-CURE THE RESTORATION FOR THE PATIENT. REGULATORY AFFAIRS WILL UPDATE THIS COMPLAINT IF NEW INFORMATION IS RECEIVED. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT EIGHT (8) PATIENTS HAD EXPERIENCED SENSITIVITY AFTER PLACEMENT OF THE SONICFILL PRODUCT. THIS IS THE SIXTH OF EIGHT (8) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194902 SONICFILL COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R