BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSIX C+ PLASTIC MATERIAL

    MDR report key: 1022011 · Received March 31, 2008

    Report

    Report Number
    2310178-2008-00024
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    December 28, 2007
    Report Date
    March 5, 2008
    Manufacturer
    DENTSPLY RAINTREE ESSIX
    Product Code
    MQC
    PMA / PMN Number
    K062828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNK, IF THE PLASTIC USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PT'S SYMPTOMS, IT IS POSSIBLE AS 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. THE DEVICE WAS NOT RETURNED FOR EVAL AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT DEVELOPED SORES IN THE MOUTH APPROXIMATELY 1-2 DAYS AFTER COMMENCING USE OF AN APPLIANCE FASHIONED USING ESSIX C+ PLASTIC MATERIAL. THE SYMPTOMS RESOLVED 1-2 DAYS AFTER USE WAS DISCONTINUED; NO INTERVENTION WAS REQUIRED AS A RESULT.

    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 21 YR Other DENTAURUM QUICK SET IMPRESSION MATERIAL| KLEENITE DENTURE CLEANSER