BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSIX C+

    MDR report key: 1032878 · Received April 23, 2008

    Report

    Report Number
    2310178-2008-00041
    Event Type
    Injury
    Date Received
    April 23, 2008
    Report Date
    March 26, 2008
    Manufacturer
    DENTSPLY RAINTREE ESSIX
    Product Code
    MQC
    PMA / PMN Number
    K062828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT APPEARS THAT THE REPORTED SYMPTOMS ARE NOT LIKELY THE RESULT OF AN ALLERGIC REACTION TO THE APPLIANCE, CONSIDERING THE VIRAL INFECTION DIAGNOSIS, ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. CONSIDERING THIS, THE FACT THAT ORAL ANTIBIOTICS WERE ADMINISTERED, AND PREVIOUS REPORTS OF ALLERGIC REACTIONS INVOLVING THIS MATERIAL, DENTSPLY HAS DECIDED TO REPORT THIS EVENT. THE DEVICE IS AVAILABLE FOR EVAL, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX ONE WEEK AFTER COMMENCING USE OF AN APPLIANCE FASHIONED USING ESSIX C+ PLASTIC MATERIAL, THE PT DEVELOPED A "DEEP ULCER-LIKE SORE" IN THE MOUTH; SEVERAL DAYS LATER, SORES DEVELOPED ON THE INSIDE OF THE CHEEKS, GUMS, LIPS, AND TONGUE. AS A RESULT, THE PT WAS ADMINISTERED ORAL ANTIBIOTICS. ALSO, DURING THE INITIAL VISIT, THE TREATING CLINICIAN DIAGNOSED THE PT WITH A VIRAL INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention