BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2456337 · Received February 13, 2012

    Report

    Report Number
    2953749-2012-00043
    Event Type
    Other
    Date Received
    February 13, 2012
    Date of Event
    December 1, 2011
    Report Date
    February 6, 2012
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALIGNERS ARE NOT BEING EVALUATED (METHOD) AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECS (RESULTS CONCLUSION) AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS (RESULTS). THIS EVENT IS BEING FILED AS AN MDR, BECAUSE THE TREATING DOCTOR CONSIDERED THE RESPIRATORY PROBLEMS MAY HAVE BEEN AN INDICATION OF ANAPHYLAXIS AND THAT THE EVENT WAS SERIOUS AND COULD HAVE BECOME LIFE THREATENING TO THE PT IF MEDICAL ATTENTION WAS NOT SOUGHT. THE PT INDICATED VISITING THE ER, BUT NO DIAGNOSIS OR ADD'L REPORTS WERE PROVIDED. NO EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN PRODUCT CAUSED OR CONTRIBUTED TO THE PT SYMPTOMS. BASED ON THE TREATING DOCTOR'S OPINION OF THE POTENTIAL ANAPHYLAXIS, AND 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 TREATMENT STARTED IN (B)(6) 2011. THE PT REPORTED RESPIRATORY PROBLEMS AND HIVES, ITCHINESS IN THROAT (DATE UNK). THE PT INDICATED VISITING THE EMERGENCY ROOM (ER) (DATE UNK), BUT NO DIAGNOSIS OR ADD'L REPORTS WERE PROVIDED. THE PT DISCONTINUED THE TREATMENT AND 3 DAYS LATER THE SYMPTOMS DISAPPEARED. THE TREATING DOCTOR CONSIDERED THE RESPIRATORY PROBLEM MAY HAVE BEEN AN INDICATION OF ANAPHYLAXIS AND THAT THE EVENT WAS SERIOUS AND COULD HAVE BECOME LIFE THREATENING TO THE PT IF MEDICAL ATTENTION WAS NOT SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 1232661

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other