BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2249622 · Received August 17, 2011

    Report

    Report Number
    2953749-2011-00102
    Event Type
    Other
    Date Received
    August 17, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALIGNERS ARE NOT BEING EVALUATED (METHOD) AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECIFICATIONS. (RESULTS, CONCLUSION) AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS (RESULTS).

    Description of Event or Problem · 1

    THE PT STARTED TREATMENT ON (B)(6) 2011. SYMPTOMS WERE REPORTED TO DOCTOR ON (B)(6) 2011, OF REPEATED EPISODES OF COUGHING, ITCHY GUMS, SWOLLEN TONGUE AND THROAT, WITH DIFFICULTY BREATHING. THE PT IS KNOWN TO HAVE ASTHMA AND SOME SEASONAL ALLERGY HISTORY. THE PT WENT TO THE EMERGENCY ROOM (ER) DUE TO BREATHING DIFFICULTIES. THE PT IS CURRENTLY TAKING SINGULAIR AS HER ASTHMA MEDICATIONS. THE TREATING DOCTOR BELIEVES THAT THIS SITUATION WAS VERY SERIOUS SINCE THE PT HAD BREATHING DIFFICULTIES. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2011. THE PT IS DOING MUCH BETTER TODAY, BUT STILL COUGHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN EXPRESS 87916053

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other