BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 1961714 · Received January 11, 2011

    Report

    Report Number
    2953749-2008-00264
    Event Type
    Other
    Date Received
    January 11, 2011
    Date of Event
    October 29, 2008
    Report Date
    December 9, 2008
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K981095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 OBSERVATIONS, (B)(4) ISSUED ON (B)(4) 2010.

    Description of Event or Problem · 1

    THE ATTENDING PHYSICIAN'S OFFICE REPORTED THAT PT EXPERIENCED SWOLLEN GLANDS, SWELLING OF THE THROAT, NOSE BLEED, YELLOW MUCUS DISCHARGE, ABDOMINAL WELTS AND A COUGH SINCE BEGINNING TREATMENT ON (B)(6) 2008. THE PT ALSO IDENTIFIED THAT SHE WAS UNDERGOING A "DETOXIFICATION FROM PLASTIC." THE PT WAS EXAMINED BY HER MEDICAL PHYSICIAN WHO WAS UNABLE TO PROVIDE A DIAGNOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN EXPRESS 46216798

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention