BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MTML-CLEAR ALIGNER-DUAL ARCH

    MDR report key: 6695238 · Received July 7, 2017

    Report

    Report Number
    1036212-2017-00004
    Event Type
    Injury
    Date Received
    July 7, 2017
    Report Date
    July 7, 2017
    Manufacturer
    RAINTREE ESSIX INC.
    Product Code
    NXC
    PMA / PMN Number
    K163155
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. ALSO, A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED HER FIRST SET OF MTM ALIGNERS AND THE DENTIST SEATED THE ALIGNERS IN THE PATIENT'S MOUTH. AFTER APPROXIMATELY 15 MINUTES, THE PATIENT COMPLAINED THAT HER GUMS WERE ITCHING. THE DOCTOR REMOVED THE ALIGNERS AND THE PATIENT'S GUMS WERE SWOLLEN. THE DOCTOR ADMINISTERED BENADRYL TO COMBAT THE SYMPTOMS. THE DOCTOR STATED THEY HAVE BEEN TRYING TO FOLLOW-UP WITH THE PATIENT, BUT THE PATIENT HAS NOT YET RETURNED ANY OF THEIR CALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474892 MTML-CLEAR ALIGNER-DUAL ARCH ALIGNER, SEQUENTIAL NXC RAINTREE ESSIX INC. NA 25499

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other