BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 1884947 · Received October 21, 2010

    Report

    Report Number
    2953749-2010-00082
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ALIGN TECHNOLOGY INC
    Product Code
    NXC
    PMA / PMN Number
    K981095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    IN THIS CASE, THE ALIGNERS ARE NOT BEING EVALUATED BECAUSE: THE ALIGNERS PERFORMED IN ACCORDANCE TO SPECIFICATIONS. IT IS KNOWN THAT ON RARE OCCASION, ALIGNERS MAY CAUSE ALLERGIC IN PTS. THIS CAUTION IS LISTED IN THE INSTRUCTIONS FOR USE. IN THIS CASE, THERE WAS NO CONCLUSIVE EVIDENCE SHOWING THAT THE ALIGNERS WERE THE CAUSAL AGENTS FOR THE PTS SIGNS OR SYMPTOMS OF AN ALLERGIC REACTION.

    Description of Event or Problem · 1

    THE TREATING DENTIST REPORTED THIS EVENT TO ALIGN TECHNOLOGY ON (B)(6) 2010. PT'S MALOCCLUSION TREATMENT WITH ALIGNERS WAS STARTED ON (B)(6) 2010. THE PT REPLACED THE 2ND STAGE ALIGNERS WITH NEW 3RD STAGE ALIGNERS (DATE UNK) AND, PER THE DENTIST, WITHIN AN HOUR, SHE DEVELOPED RASH OVER HER BODY AND SWELLING OF THE THROAT WITH PAIN ON ITS LEFT SIDE. THE PT WENT TO A DERMATOLOGIST ON (B)(6) 2010 AND WAS TESTED FOR FOOD ALLERGY AND OTHER BLOOD TESTS WERE DONE ON (B)(6) 2010. THE TESTS RESULTS WERE INCONCLUSIVE EXCEPT FOR IGE BEING HIGH (387) IMPLYING AN ALLERGIC REACTION. THE PT STOPPED HER TREATMENT WITH ALIGNERS ON THE (B)(6) 2010. SHE REPORTED THIS INCIDENCE TO THE DENTIST ON (B)(6) 2010, WHO ALSO AGREED WITH DISCONTINUING USE OF THOSE ALIGNERS. THE DENTIST REPORTED, THE EVENT TO ALIGN ON (B)(6) 2010. SINCE THE DIS-CONTINUATION OF TREATMENT, THE PT IS A LITTLE BETTER THOUGH, SHE STILL HAS THE LESIONS. AT THIS POINT, THERE IS NO CONCLUSIVE EVIDENCE THAT THE PT HAD AN ALLERGIC REACTION TO THE ALIGNERS. THE DENTIST PLANS TO EVALUATE THE PT NEXT WEEK AND IF SIGNIFICANT INFO IS GATHERED, ALIGN WILL UPDATE THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY INC EXPRESS 71967235

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention