BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 3133687 · Received May 24, 2013

    Report

    Report Number
    2953749-2013-00134
    Event Type
    Other
    Date Received
    May 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALIGNERS ARE NOT BEING EVALUATED AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECIFICATIONS AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS. THIS EVENT IS BEING FILED AS AN MDR, BECAUSE THE PT'S REPORTED SYMPTOMS WERE DIAGNOSED AS ANGIOEDEMA BY A GENERAL PHYSICIAN. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN PRODUCT CAUSE OR CONTRIBUTED TO THE DIAGNOSIS OF ANGIOEDEMA OR REPORTED SYMPTOMS. SINCE THE INVISALIGN PRODUCT WAS BEING USED AT THE TIME OF THE REPORTED SYMPTOMS, AN MDR IS BEING FILED.

    Description of Event or Problem · 1

    THE SYMPTOMS REPORTED BY THE PT WERE EYES AND FACIAL INFLAMMATION AND SWOLLEN TONGUE. THE PT INDICATED VISITING A GENERAL PHYSICIAN. THE PT REPORTED BEING PRESCRIBED BENADRYL (ANTIHISTAMINE) AND PREDNISONE (STEROIDS) TO ALLEVIATE THE REPORTED SYMPTOMS. THE PT ALSO INDICATED THAT THE GENERAL PHYSICIAN DIAGNOSED THE REPORTED SYMPTOMS AS ANGIOEDEMA (UNK ORIGIN) AND NO ADDITIONAL INFORMATION WAS PROVIDED. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231077 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 9434150

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other