BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2249589 · Received August 29, 2011

    Report

    Report Number
    2953749-2011-00110
    Event Type
    Other
    Date Received
    August 29, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 22, 2011
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    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 (METHOD) AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECIFICATIONS (RESULTS & CONCLUSION) AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS (RESULTS). THE PT'S SYMPTOMS OF DIFFICULTY IN BREATHING, A SENSATION OF THROAT CLOSING AND A CONSTRICTED AIRWAY ARE DEEMED POTENTIALLY SERIOUS IN NATURE. THE PT WENT TO THE EMERGENCY ROOM BUT NO MEDICAL REPORT OR DIAGNOSIS WAS PROVIDED. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN PRODUCT CAUSED OR CONTRIBUTED TO THE PT SYMPTOMS. SINCE THE INVISALIGN PRODUCT WAS BEING USED AT THE TIME OF THE REPORTED SYMPTOMS, AND THE TREATING DOCTOR CONSIDERS THIS EVENT TO HAVE BEEN POTENTIALLY SERIOUS OR LIFE THREATENING TO THE PT, AN MDR IS BEING FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE TREATING DOCTOR REPORTED THAT THE TREATMENT STARTED ON (B)(6), 2011, USING ALIGNER STAGE #1. THE PT REPORTED SYMPTOMS ON (B)(6), 2011, OF DIFFICULTY IN BREATHING, A SENSATION OF THROAT CLOSING AND CONSTRICTED AIRWAY. ACCORDING TO DR SWIFT THERE IS NO ALLERGY HISTORY REPORTED AND THE PT IS NOT CURRENTLY TAKING ANY MEDICATIONS. THE PT WENT TO THE ER BUT NO MEDICAL REPORT OR DIAGNOSIS WAS PROVIDED. ACCORDING TO DR SWIFT THERE IS NO INDICATION OF ANAPHYLAXIS OR HEREDITARY ANGIOEDEMA ON THE PT'S MEDICAL HISTORY. DR SWIFT CONSIDERS THIS EVENT WAS A SERIOUS OR LIFE THREATENING TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 91979559

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other