BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSIX C+ PLASTIC MATERIAL

    MDR report key: 5617728 · Received April 28, 2016

    Report

    Report Number
    1036212-2016-00004
    Event Type
    Injury
    Date Received
    April 28, 2016
    Report Date
    March 29, 2016
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    MQC
    PMA / PMN Number
    K062828
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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.

    Description of Event or Problem · 1

    A CLINICIAN REQUESTED A MSDS SHEET BECAUSE THEY HAVE A PATIENT THAT HAD A SEVERE ALLERGIC REACTION TO ESSIX C+ PLASTIC MATERIAL. NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269153 ESSIX C+ PLASTIC MATERIAL MOUTHGUARD, PRESCRIPTION MQC RAINTREE ESSIX INC. NA 00014447

    Patients

    Seq Age Sex Outcome Treatment
    1 Other