BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMISE

    MDR report key: 4031156 · Received August 22, 2014

    Report

    Report Number
    2024312-2014-00589
    Event Type
    Injury
    Date Received
    August 22, 2014
    Report Date
    August 1, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K032921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO THE EXACT NUMBER INVOLVED, GENDERS, AGES, OR WEIGHTS COULD NOT BE RECALLED BY THE DOCTOR. ALTHOUGH THE DOCTOR IDENTIFIED THREE (3) DIFFERENT LOTS ASSOCIATED WITH THE COMPOSITE NOT FULLY POLYMERIZING, THE DOCTOR COULD NOT VERIFY WHICH LOT HAD BEEN USED ON ANY OF THE PATIENTS; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENT INCLUDE LOT NUMBERS 4890803, 4952168, 4946447, 4952165, 4961925, 5044009, 5119317, 4923681, 5044012, 5137498, AND 4951208. THE DOCTOR DRILLED OUT THE COMPOSITE AND REPLACED THE RESTORATION DURING THE SAME OFFICE VISIT FOR EACH OF THE PATIENTS. TO DATE, EACH OF THE PATIENTS ARE DOING FINE. RETURNED PRODUCTS FROM LOT NUMBERS 4952168, 4946447, AND 5044009 WERE TESTED FOR DEPTH OF CURE, YIELDING RESULTS WITHIN SPECIFICATIONS. THE PRODUCT FROM LOT NUMBERS 4890803, 4952165, 4961925, AND 5119317 WAS RETURNED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE; THEREFORE, A PHYSICAL EVALUATION WAS PERFORMED ON A RETAINED SAMPLE, YIELDING RESULTS WITHIN SPECIFICATIONS. RETURNED PRODUCT FROM LOT NUMBERS 4923681, 5044012, 5137498, AND 4951208 WERE TESTED FOR DEPTH OF CURE. THE PRODUCTS DID NOT MEET SPECIFICATIONS; THEREFORE, RETAINED SAMPLES FROM EACH OF THE LOTS WERE EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS. SINCE BOTH THE DHR AND RETAINED SAMPLES SHOW LOT NUMBERS 4923681, 5044012, 5137498, AND 4951208 TO BE MANUFACTURED AND TESTING WITHIN SPECIFICATIONS, IT HAS BEEN CONCLUDED THAT THE RETURNED PRODUCT FROM THESE LOTS WAS COMPROMISED IN THE FIELD, MOST LIKELY DUE TO IMPROPER STORAGE CONDITIONS. PER THE INSTRUCTIONS FOR USE, PREMISE COMPOSITE MUST BE KEPT AT AMBIENT TEMPERATURE.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE PREMISE COMPOSITE DID NOT FULLY POLYMERIZE DURING PROCEDURES ON MULTIPLE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509987 PREMISE TOOTH SHADE RESIN MATERIAL EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R