BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSIX + PLASTIC 80 CT .040 (1 MM) -125MM CIRCLE

    MDR report key: 5684259 · Received May 27, 2016

    Report

    Report Number
    1036212-2016-00007
    Event Type
    Injury
    Date Received
    May 27, 2016
    Date of Event
    March 1, 2016
    Report Date
    April 28, 2016
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    MQC
    PMA / PMN Number
    K062828
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT IS UNKNOWN IF THE DEVICE USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'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. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH MANY ALLERGIES, EXPERIENCED AN ALLERGIC REACTION WHILE WEARING AN ORTHODONTIC APPLIANCE MADE WITH ESSIX+ PLASTIC MATERIAL. THE SYMPTOMS REPORTED WERE WHITE SPOTS ON THE PATIENT'S TONGUE. NO MEDICAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341273 ESSIX + PLASTIC 80 CT .040 (1 MM) -125MM CIRCLE MOUTHGUARD, PRESCRIPTION MQC RAINTREE ESSIX INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other