BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULITE ULTRA

    MDR report key: 4171055 · Received October 14, 2014

    Report

    Report Number
    2024312-2014-00658
    Event Type
    Injury
    Date Received
    October 14, 2014
    Report Date
    September 17, 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. THE PATIENT HAD EXPERIENCED SENSITIVITY AND RETURNED TO THE DENTAL OFFICE. THE DOCTOR REMOVED THE PATIENTS RESTORATIONS AND REPLACED THEM WITH TEMPORARY FILLINGS. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE COMPLAINANT ON (B)(6) 2014 IN ORDER TO OBTAIN FURTHER PATIENT HEALTH STATUS 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.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, THE DOCTOR REPORTED THAT SIX (6) LOT NUMBERS WERE ASSOCIATED WITH THE ALLEGED INCIDENT. 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; THEREFORE, NO CATALOG NUMBERS OR LOT NUMBERS WERE IDENTIFIED OF THIS REPORT. 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) WERE ASSOCIATED WITH THE ALLEGED INCIDENT. THE DOCTOR ALSO REPORTED THAT THE PATIENT HAD RETURNED TO THE OFFICE AND THE FINAL RESTORATION WAS COMPLETED. 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

    A DOCTOR'S OFFICE ALLEGED THAT THREE (3) PATIENTS HAD EXPERIENCED PAIN AND SENSITIVITY DUE TO HERCULITE ULTRA RESTORATIONS WHICH HAD NOT FULLY POLYMERIZED AND HAD SEPARATED FROM THE TOOTH. THIS IS THE THIRD OF THREE (3) REPORTS.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A DOCTOR'S OFFICE HAD INITIALLY ALLEGED THAT THREE (3) PATIENTS HAD EXPERIENCED PAIN AND SENSITIVITY DUE TO HERCULITE ULTRA RESTORATIONS WHICH HAD NOT FULLY POLYMERIZED; HOWEVER, DURING A FOLLOW UP PHONE CALL ON (B)(6) 2014 WITH THE OFFICE, IT WAS REPORTED THAT AN ADDITIONAL THREE (3) PATIENTS HAD EXPERIENCED SENSITIVITY AFTER PLACEMENT OF HERCULITE ULTRA RESTORATIONS. THIS IS THE THIRD OF SIX (6) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650765 HERCULITE ULTRA MATERIAL, TOOTH SHADE, RESIN EBF KERR CORPORATION

    Patients

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