BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULITE ULTRA

    MDR report key: 1943283 · Received December 31, 2010

    Report

    Report Number
    2024312-2010-00106
    Event Type
    Injury
    Date Received
    December 31, 2010
    Report Date
    December 1, 2010
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K082671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR ALLEGED THAT THE HERCULITE ULTRA USED IN THE RESTORATIONS OF THREE PATIENTS BROKE THROUGH THE MIDDLE OF THE MATERIAL. NO FURTHER INFORMATION ON THE INCIDENTS WAS PROVIDED. FIVE ATTEMPTS WERE MADE TO CONTACT THE OFFICE FOR ADDITIONAL INFORMATION ON 12-03-10, 12-06-10, 12-10-10, 12-13-10 AND 12-17-10. HOWEVER, NO RESPONSE WAS RECEIVED. NO PRODUCT WAS RETURNED FROM THE CUSTOMER FOR EVALUATION AND NO PRODUCT LOT NUMBER WAS PROVIDED; THEREFORE NO FURTHER INVESTIGATION IS POSSIBLE AND THE CAUSE FOR THE INCIDENT REMAINS INCONCLUSIVE.

    Description of Event or Problem · 1

    ON (B)(6), 2010, A DOCTOR REPORTED THAT THE HERCULITE ULTRA USED IN A PATIENT'S RESTORATIONS BROKE THROUGH THE MIDDLE OF THE MATERIAL. NO FURTHER DETAILS WERE PROVIDED. THIS IS THE SECOND OF THREE REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERCULITE ULTRA MATERIAL, TOOTH SHADE, RESIN EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other