BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2020239 · Received March 9, 2011

    Report

    Report Number
    2953749-2011-00028
    Event Type
    Other
    Date Received
    March 9, 2011
    Date of Event
    August 1, 2010
    Report Date
    February 28, 2011
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K981095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    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 LABEL INDICATIONS. THE TREATING PHYSICIAN BELIEVES THAT THIS COULD HAVE BEEN A MILD ANAPHYLACTIC REACTION, MEDICATION WAS TAKEN BY THE PT TO ALLEVIATE THE REPORTED SYMPTOMS. WITHOUT ADDITIONAL MEDICAL TREATMENTS, INFO OR TESTING, WE ARE UNABLE TO CONCLUDE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE PTS SYMPTOMS, OR WHETHER THE PT TRULY HAD A MILD ANAPHYLACTIC REACTION. THUS, THIS EVENT IS BEING REPORTED.

    Description of Event or Problem · 1

    THE PT STARTED TREATMENTS WITH FIRST STAGE OF ALIGNERS, DELIVERED ON (B)(6) 2010. THE PT FIRST REPORTED SYMPTOMS ON (B)(6) 2011, BUT NOTED THE SYMPTOMS STARTED IN (B)(6) 2010. SYMPTOMS REPORTED: SWOLLEN TONGUE, RASH ALL OVER FACE, AND ON (B)(6) 2011, THE PT IDENTIFIED THAT IT WAS DIFFICULT TO SWALLOW. THE TREATING DOCTOR STOPPED THE TREATMENTS AT STAGE 12 OF 18. THE PT IDENTIFIED ALLERGIES TO ASPIRIN, JEWELRY, METALS, PENICILLIN, AND SEASONAL ALLERGIES. TO ALLEVIATE THE SYMPTOMS, THE PT REPORTEDLY TOOK A CORTISONE INJECTION, AND IS NOW SYMPTOM FREE. THE PT IS SCHEDULED TO SEE AN ALLERGIST. THE TREATING PHYSICIAN BELIEVES THAT THE PT COULD HAVE HAD A MILD ANAPHYLACTIC REACTION, BASED ON THE REPORTED BREATHING DIFFICULTIES. THUS, THIS EVENT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 71634393

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other