BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICFILL COMPOSITE

    MDR report key: 3063400 · Received April 17, 2013

    Report

    Report Number
    2024312-2013-00142
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 22, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K091023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC INFORMATION WITH REGARD TO PATIENT GENDER, AGE, WEIGHT, AND NUMBER AFFECTED WERE NOT PROVIDED BY THE DOCTOR. THE PATIENTS RETURNED TO THE OFFICE AND THE DOCTOR REMOVED THE SONICFILL MATERIAL. THE RESTORATIONS WERE REPLACED USING A DIFFERENT COMPOSITE MATERIAL, WITHOUT FURTHER INCIDENT. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE COMPLAINANT IN ORDER TO OBTAIN FURTHER INCIDENT INFORMATION; HOWEVER, THE COMPLAINANT HAS REMAINED UNRESPONSIVE. 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 MULTIPLE PATIENTS HAD EXPERIENCED SENSITIVITY AFTER PLACEMENT OF THE SONICFILL PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164722 SONICFILL COMPOSITE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R SUREFIL FLOWABLE| SCOTCHBOND UNIVERSAL