BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 1961713 · Received January 11, 2011

    Report

    Report Number
    2953749-2009-00068
    Event Type
    Other
    Date Received
    January 11, 2011
    Date of Event
    May 15, 2009
    Report Date
    May 15, 2009
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K981095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED OUTSIDE THE 30 DAY REQUIREMENT, AS THIS MDR FILING IS RELATED TO ALIGN TECHNOLOGY'S (B)(4) BASED ON FORM FDA (B)(4) INSPECTION OBSERVATION, (B)(4) ISSUED ON (B)(4) 2010.

    Description of Event or Problem · 1

    THE PT REPORTED THAT WHEN WEARING THE FIRST SET OF ALIGNERS, THE PT HAD SOME ITCHING IN HER THROAT. SHE REMOVED THEM AND RETRIED THEM AGAIN AFTER A WHILE, AND THE SYMPTOMS RETURNED. THE DENTIST REPORTED THAT THE PT EXPERIENCED IRRITATION ON HER LIPS AND THAT IT BECAME SO SEVERE THAT HER THROAT FELT LIKE IT WAS CLOSING UP. THE PT IMMEDIATELY TOOK BENADRYL, AND DISCONTINUED HER TREATMENT FOR FIVE DAYS AND THE SYMPTOMS SUBSIDED. THE PT TRIED THE ALIGNERS AGAIN, BUT THE SYMPTOMS REAPPEARED WITHIN 15-20 MINUTES. DR STATED THAT THE PT'S GUMS WERE SENSITIVE, AND THAT HER LIPS AND TONGUE WERE SWOLLEN. THE PT SAW HER GENERAL PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 53210917

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other