BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 6052453 · Received October 24, 2016

    Report

    Report Number
    2953749-2016-00882
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    September 1, 2016
    Report Date
    October 21, 2016
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO TEST METHODS HAVE BEEN PERFORMED AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECIFICATIONS AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THAT FACT THAT THE INVISALIGN SYSTEM ALIGNERS CAUSED OR CONTRIBUTED TO THE PATIENTS SYMPTOMS. THIS EVENT IS BEING FILED AS AN MDR SINCE THE PATIENT REPORTED THE SYMPTOM OF ANAPHYLACTIC EPISODE WHILE THE INVISALIGN SYSTEM ALIGNERS WERE BEING USED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SYMPTOMS OF ASTHMA ATTACK, DIFFICULTY BREATHING, ANAPHYLACTIC EPISODE, NAUSEA, HEADACHES, SMALL BLISTERS ON THE TONGUE, HIVES/ITCHING OF THE FACE AND NECK, SORE LIPS AND THROAT, COUGHING/SNEEZING/WHEEZING, MOUTH DISCOMFORT AND DRYNESS OF MOUTH. THE PATIENT DID NOT REPORT REQUIRING ANY MEDICAL INTERVENTION DUE TO THE REPORTED SYMPTOMS. THE PATIENT DID NOT REPORT TAKING OR BEING PRESCRIBED ANY MEDICATION DUE TO THE REPORTED SYMPTOMS. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2016 AND THE PATIENT IS CURRENTLY FINE. THE TREATING DOCTOR DID NOT CONSIDER THE EVENT WAS SERIOUS OR LIFE THREATENING TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701782 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS NXC ALIGN TECHNOLOGY, INC. INVISALIGN LITE 11813916

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other