BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTML-CLEAR ALIGNER-DUAL ARCH

    MDR report key: 5583122 · Received April 15, 2016

    Report

    Report Number
    1036212-2016-00003
    Event Type
    Injury
    Date Received
    April 15, 2016
    Date of Event
    March 15, 2016
    Report Date
    March 15, 2016
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    NXC
    PMA / PMN Number
    K132145
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION TO HER MTM ALIGNER. WHILE WEARING THE ALIGNER, THE PATIENT HAS IRRITATION AND SWELLING. WHEN SHE REMOVES THE ALIGNER, THE SYMPTOMS SUBSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236806 MTML-CLEAR ALIGNER-DUAL ARCH ALIGNER, SEQUENTIAL NXC RAINTREE ESSIX INC. NA 11103

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other