BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 1961689 · Received January 11, 2011

    Report

    Report Number
    2953749-2009-00018
    Event Type
    Other
    Date Received
    January 11, 2011
    Date of Event
    February 5, 2009
    Report Date
    February 11, 2009
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K981095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 STARTED TREATMENT ON (B)(6) 2009 AND DID WELL THE FIRST WEEK. PT HAD MILD SYMPTOMS THE SECOND WEEK OF WEARING THE ALIGNERS AND STRONGER SYMPTOMS AFTER THAT, AROUND (B)(6) 2009. PT DISCONTINUED TREATMENT ON (B)(6) 2009 AND HER SYMPTOMS GREATLY DECREASED THE NEXT DAY. PT REPORTED SYMPTOMS OF INCREASED BLOOD PRESSURE AND HEART RATE, PT FELT SHAKY, UNSTEADY, UNCOMFORTABLE, HAD A RASPY AND HOARSE VOICE. ON (B)(6) 2009, PT SAW HER ALLERGIST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention