BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 1943794 · Received December 17, 2010

    Report

    Report Number
    2953749-2010-00111
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 6, 2010
    Manufacturer
    ALIGN TECHNOLOGY
    Product Code
    NXC
    PMA / PMN Number
    K981095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT APPEARS TO HAVE EXPERIENCED AN ALLERGIC REACTION AFTER STARTING THE USE OF THE INVISALIGN FULL ALIGNER.

    Description of Event or Problem · 1

    DR (B)(6) SAID THAT THE PT STARTED TO SUFFER A LOT OF SALIVATION WHILE WEARING THE ALIGNERS (DR DOES NOT RECALL THE DATE OF ALIGNER DELIVERY). IN (B)(6), THE PT WENT TO HER GENERAL DENTIST AND HE THOUGHT IT WAS RELATED TO THE TOOTH PASTE. SO THE PT CHANGED THE TOOTH PASTE AND HAD SOME STEROID RINSES. ON (B)(6) 2010, THE PT CALLED THE DR AND SAID SHE STOPPED WEARING THE ALIGNERS LAST WEEK AND SYMPTOMS SEEMED TO IMPROVE. SHE PUT THEM IN LAST NIGHT AND THE ORIGINAL SYMPTOM RETURNED AND NEW SYMPTOMS ALSO DEVELOPED. SYMPTOMS REPORTED: SORES ON CHEEKS AND PALATE, THROAT FELT CLOSED, DIFFICULTY SWALLOWING, BURNING SENSATION AND EXCESSIVE SALIVATION. PT HAS NO HISTORY OF ALLERGIES, AND IS NOT TAKING ANY MEDICATION, IN ORDER TO ALLEVIATE THE SYMPTOMS SHE JUST REMOVED THE TRAYS AND SYMPTOMS IMPROVED. AT THIS MOMENT, THE PT IS NOT WEARING THE ALIGNERS. THERE IS NO INDICATION OF ANAPHYLAXIS OR HEREDITARY ANGIOEDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS -ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY INVISALIGN FULL 57988620

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention