BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2163636 · Received June 8, 2011

    Report

    Report Number
    2953749-2011-00068
    Event Type
    Other
    Date Received
    June 8, 2011
    Date of Event
    May 5, 2011
    Report Date
    June 6, 2011
    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 SPCS AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS. THE TREATING DOCTOR THINKS THAT THIS EVENT WAS SERIOUS AND POTENTIALLY LIFE THREATENING TO THE PT. THUS, THIS EVENT IS BEING REPORTED.

    Description of Event or Problem · 1

    THE PT STARTED TREATMENT ON (B)(6) 2011. SYMPTOMS WERE REPORTED TO THE DOCTOR ON (B)(6) 2011, A FEW DAYS AFTER RECEIVING THE FIRST ALIGNER, THE PT DEVELOPED COUGHING, ITCHINESS IN MOUTH, AND BRONCHITIS. THE PT WENT TO HER GENERAL PHYSICIAN WHO CONFIRMED THAT THE PT'S AIRWAYS WERE REDUCED AT THAT MOMENT AND THAT IT COULD BE CAUSED BY THE ALIGNERS. THE PT WENT TO EMERGENCY ROOM AND HAD A BATTERY OF TESTS PERFORMED, WHICH DEMONSTRATED THAT THE PT HAD AN ALLERGIC REACTION. IT IS UNK IF THE PT NEEDED MEDICATIONS TO ALLEVIATE THE REPORTED SYMPTOM. THE PT DISCONTINUED THE ALIGNERS AND GOT BETTER, SHE IS NOW BACK TO NORMAL. THE TREATING DOCTOR THINKS THAT THIS EVENT WAS SERIOUS AND POTENTIALLY LIFE THREATENING TO THE PT. THERE WAS NO INDICATION OF ANAPHYLAXIS OR HEREDITARY ANGIOEDEMA. THE PT DECIDED TO DISCONTINUE THE TREATMENT. TREATMENT WAS DISCONTINUED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC INVISALIGN FULL 84261151

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other