BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULITE ULTRA

    MDR report key: 4306025 · Received December 8, 2014

    Report

    Report Number
    2024312-2014-00676
    Event Type
    Injury
    Date Received
    December 8, 2014
    Report Date
    November 10, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K082671
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION SUCH AS AGE AND WEIGHT WAS NOT PROVIDED. ALTHOUGH THE DOCTOR IDENTIFIED SIX (6) DIFFERENT LOTS ASSOCIATED WITH THE SENSITIVITY ISSUES, THE DOCTOR COULD NOT VERIFY WHICH LOT WAS USED ON ANY OF THE PATIENTS. THE LOTS INVOLVED IN THE ALLEGED INCIDENT INCLUDE LOT NUMBERS 4887139 (CATALOG #34349), 4880077 (CATALOG #34776), 4444999 (CATALOG #34350), 4734549 (CATALOG #34448), AND TWO (2) UNKNOWN LOT NUMBERS (CATALOG #34347 AND #34348). THE DOCTOR REMOVED AND REPLACED THE PATIENT'S RESTORATION USING A DIFFERENT PRODUCT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED. A VISUAL AND PHYSICAL EVALUATION WAS PERFORMED ON RETAINED SAMPLES FROM THE SAME LOTS FOR LOT NUMBERS 4887139, 4880077, AND 4734549, YIELDING RESULTS WITHIN SPECIFICATIONS. THE LOT NUMBER 4444999 WAS EXPIRED PRODUCT; THEREFORE, NO FURTHER EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A DOCTOR'S OFFICE HAD ALLEGED THAT SIX (6) PATIENTS HAD EXPERIENCED PAIN AND SENSITIVITY AFTER PLACEMENT OF RESTORATIONS USING THE HERCULITE ULTRA PRODUCT. THIS IS THE SIXTH OF SIX (6) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789928 HERCULITE ULTRA MATERIAL, TOOTH SHADE, RESIN EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R OPTIBOND SOLO PLUS