BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMISE PACKABLE

    MDR report key: 3930352 · Received July 11, 2014

    Report

    Report Number
    2024312-2014-00513
    Event Type
    Injury
    Date Received
    July 11, 2014
    Report Date
    July 2, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K032921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCTS FROM LOT NUMBERS 4657398 AND 4659614 WERE TESTED FOR DEPTH OF CURE. THE PRODUCTS DID NOT MEET SPECIFICATIONS; THEREFORE, RETAINED SAMPLES FROM BOTH LOTS WERE EVALUATED, YIELDING RESULTS WITHIN SPECIFICATIONS. SINCE NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED WITH REGARD TO THESE LOTS, AND BOTH THE DHR AND RETAINED SAMPLES SHOW THESE LOTS TO BE MANUFACTURED AND TESTING WITHIN SPECIFICATIONS, IT HAS BEEN CONCLUDED THAT THE RETURNED PRODUCT FROM LOT NUMBERS 4657398 AND 4659614 WAS COMPROMISED IN THE FIELD, MOST LIKELY DUE TO IMPROPER STORAGE CONDITIONS. PER THE INSTRUCTIONS FOR USE, PREMISE PACKABLE IS INTENDED TO BE KEPT AT AMBIENT TEMPERATURE. RETURNED PRODUCTS FROM LOT NUMBERS 4920717 AND 4703727 WERE EVALUATED FOR DEPTH OF CURE, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO BOTH OF THESE LOTS.

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE, AND WEIGHT WAS NOT PROVIDED. ALTHOUGH THE OFFICE IDENTIFIED FOUR (4) DIFFERENT LOTS ASSOCIATED WITH THE COMPOSITE NOT POLYMERIZING, THE OFFICE COULD NOT VERIFY WHICH LOT HAD BEEN USED ON THE PATIENT; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN SECTION D-4 OF THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENT INCLUDE LOT NUMBERS 4657398, 4703727, 4659614, AND 4920717. THE PATIENT RETURNED TO THE OFFICE AND THE DOCTOR REMOVED THE COMPOSITE. THE RESTORATION WAS REPLACED USING A DIFFERENT PRODUCT. TO DATE, THE PATIENT IS DOING FINE. ALTHOUGH THE DOCTOR IDENTIFIED FOUR (4) DIFFERENT LOTS ASSOCIATED WITH THE INCIDENT, THE DOCTOR COULD NOT VERIFY WHICH LOT NUMBER WAS USED ON THE PATIENT. AN EVALUATION OF PRODUCT IS EXPECTED, BUT HAS NOT YET BEGUN.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE PREMISE PACKABLE COMPOSITE DID NOT POLYMERIZE AND FOUR (4) PATIENTS HAD EXPERIENCED SENSITIVITY ISSUES TWO (2) DAYS AFTER PLACEMENT. THIS IS THE THIRD OF FOUR (4) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406046 PREMISE PACKABLE MATERIAL, TOOTH SHADE RESIN EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TETRIC COMPOSITE