BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2249687 · Received August 25, 2011

    Report

    Report Number
    2953749-2011-00109
    Event Type
    Other
    Date Received
    August 25, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 23, 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). THE PTS SYMPTOMS OF SWOLLEN LIPS AND TONGUE ARE NOT CONSIDERED TO BE SERIOUS IN NATURE, BUT COULD BE AN INDICATOR OF AN ALLERGIC REACTION. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN PRODUCT CAUSE OR CONTRIBUTED TO THE PT SYMPTOMS. SINCE THE INVISALIGN PRODUCT WAS BEING USED AT THE TIME OF THE REPORTED SYMPTOMS. THE TREATING DOCTOR BELIEVE THE EVENT COULD HAVE BEEN SERIOUS OR LIFE THREATENING TO THE PT, THUS AN MDR IS BEING REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE TREATING DR. REPORTED THAT THE PT STARTED TREATMENT ON (B)(6) 2011 AND 4 DAYS AFTER WEARING ALIGNER STAGE #1, THE PT REPORTED FEELING SWOLLEN LIPS AND TONGUE. SYMPTOMS STARTED GRADUALLY. THE PT THOUGH THE SYMPTOMS WERE NORMAL AND HE KEPT WEARING THE ALIGNERS. TWELVE DAYS LATER THE SYMPTOMS BECAME WORSE. THE PT STOPPED USING THE ALIGNERS AND TOOK BENADRYL TO ALLEVIATE THE REPORTED SYMPTOMS AND FELT BETTER. THE TREATING DR. SAW THAT THE PT WAS HAVING REDNESS, ULCERATION ON HIS LIPS AND EDEMA ON HIS MOUTH. THE TREATING DR. CONFIRMED IT WAS AN ALLERGIC REACTION. THE TREATING DOCTOR BELIEVE THE EVENT COULD HAVE BEEN 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 92239501

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other