BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERCULITE XRV

    MDR report key: 4031122 · Received August 22, 2014

    Report

    Report Number
    2024312-2014-00588
    Event Type
    Injury
    Date Received
    August 22, 2014
    Report Date
    August 12, 2014
    Manufacturer
    KERR CORPORATION
    Product Code
    EBF
    PMA / PMN Number
    K943642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC INFORMATION REGARDING THE EXACT NUMBER OR PATIENTS INVOLVED, GENDERS, AGES, OR WEIGHTS WAS NOT PROVIDED. ALTHOUGH THE OFFICE IDENTIFIED TWENTY-TWO (22) DIFFERENT LOTS ASSOCIATED WITH THE COMPOSITE NOT FULLY POLYMERIZING, THE OFFICE COULD NOT VERIFY WHICH LOT HAD BEEN USED ON ANY OF THE PATIENTS; THEREFORE, NO LOT NUMBERS WERE IDENTIFIED IN SECTION D-4 OF THIS REPORT. THE LOTS INVOLVED IN THE ALLEGED INCIDENT INCLUDE LOT NUMBERS 3822248, 4296344, 4114310, 4269139, 4951193, 5025056, 5018742, 5114269, 5071576, 5173183, 4343500, 4359392, 4359386, 4412290, 4397292, 4359385, 5102782 , 4343503, 4730528, 4800389, 5066191, AND 4964205. THE OFFICE REPORTED THAT IN SOME AREAS THE FILLING WOULD BE FULLY SET WHEREAS OTHER AREAS OF THE FILLING WOULD STILL BE SOFT AFTER LIGHT CURING. THE DOCTOR EITHER PICKED OUT THE COMPOSITE OR DRILLED IT OUT AND REPLACED THE RESTORATION DURING THE SAME OFFICE VISIT FOR EACH OF THE PATIENTS. TO DATE, EACH OF THE PATIENTS ARE DOING FINE. THE PRODUCTS INVOLVED IN THE ALLEGED INCIDENT WERE NOT RETURNED. THE PRODUCT FROM LOT NUMBERS 3822248, 4296344, 4114310, AND 4269139, WAS EXPIRED; THEREFORE, NO EVALUATION CAN BE CONDUCTED. A PHYSICAL EVALUATION WAS PERFORMED ON RETAINED SAMPLES FROM LOT NUMBERS 4951193, 5025056, 5018742, 5114269, 5071576, 5173183, 4343500, 4359392, 4359386, 4412290, 4397292, 4359385, 5102782 , 4343503, 4730528, 4800389, 5066191, AND 4964205, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT THE HARDNESS OF THE HERCULITE XRV COMPOSITE WAS INCONSISTENT AFTER POLYMERIZATION DURING PROCEDURES ON MULTIPLE PATIENTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509144 HERCULITE XRV MATERIAL, TOOTH SHADE, RESIN EBF KERR CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R