BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSIX C+ PLASTIC MATERIAL

    MDR report key: 982001 · Received January 18, 2008

    Report

    Report Number
    2310178-2007-00235
    Event Type
    Injury
    Date Received
    January 18, 2008
    Date of Event
    December 19, 2007
    Report Date
    December 19, 2007
    Manufacturer
    DENTSPLY RAINTREE ESSIX
    Product Code
    MQC
    PMA / PMN Number
    K062828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS POSSIBLE THAT THE SYMPTOMS COULD BE THE RESULT OF ANOTHER CONDITION SUCH AS ANGULAR CHEILOSIS (WHICH CAN BE CAUSED BY CANDIDIASIS, RIBOFLAVIN DEFICIENCY, OR OVERLOAD VERTICAL DIMENSION), ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDANT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW. HOWEVER, INTRACUTANEOUS REACTIVITY TESTING WAS PREVIOUSLY PERFORMED. A SAMPLE OF ESSIX C+ WAS EXTRACTED. THE EXTRACTS WERE EVALUATED FOR INTRACUTANEOUS REACTIVITY PER ISO 10933. A DOSE OF THE APPROPRIATE TEST ARTICLE EXTRACT WAS INJECTED BY THE INTRACUTANEOUS ROUTE INTO FIVE SEPARATE SITES. THE CORRESPONDING CONTROL WAS INJECTED ON THE LEFT SIDE OF THE BACK. THE INJECTION SITES WERE OBSERVED IMMEDIATELY AFTER INJECTION AND OBSERVATIONS FOR ERYTHEMA AND EDEMA WERE CONDUCTED AT 24, 48, AND 72 HOURS. THERE WAS NO ERYTHEMA OR EDEMA FROM THE FIRST TEST EXTRACT AND VERY SLIGHT ERYTHEMA AND EDEMA FROM THE SECOND EXTRACT. THE REQUIREMENTS OF THE TEST WERE MET SINCE THE DIFFERENCE BETWEEN THE TEST EXTRACT AND CORRESPONDING CONTROL MEAN SCORE WAS < 1.0.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEVELOPED CRACKING AND BLEEDING IN THE CORNERS OF THE MOUTH AFTER USE OF A RETAINER FASHIONED USING ESSIX C+ PLASTIC MATERIAL; THERE IS NO INDICATION THAT INTERVENTION WAS REQUIRED TO TREAT THE SYMPTOMS. THE PATIENT REPORTEDLY REMOVED THE APPLIANCE FOR A ONE WEEK PERIOD ON SEVERAL OCCASIONS, WITH THE SYMPTOMS DISAPPEARING AFTER REMOVAL. UPON RESUMING USE, THE SYMPTOMS REAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESSIX C+ PLASTIC MATERIAL MQC DENTSPLY RAINTREE ESSIX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other POLIDENT| ESSIX FREEZE SPRAY