BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICFILL COMPOSITE

    MDR report key: 3180640 · Received June 20, 2013

    Report

    Report Number
    2024312-2013-00278
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 23, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K091023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC INFORMATION WITH REGARD TO THE PATIENTS SUCH AS NUMBER AFFECTED, AGE, AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. IT WAS REPORTED THAT THE BLACK SPECKS WERE NOTICED AFTER LIGHT CURING THE MATERIAL. THE DOCTOR REMOVED THE MATERIAL AND REPLACED IT FOR EACH OF THE PATIENTS. NO FURTHER INFORMATION COULD BE COLLECTED REGARDING PATIENT HEALTH AS THE COMPLAINANT DECLINED TO COMMENT ANY FURTHER REGARDING THESE INCIDENTS. THE PRODUCT HAS NOT BEEN RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT BLACK SPECKS WERE PRESENT IN THE SONICFILL TIPS DURING MULTIPLE PATIENT PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281585 SONICFILL COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R