BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 1961701 · Received January 11, 2011

    Report

    Report Number
    2953749-2009-00116
    Event Type
    Other
    Date Received
    January 11, 2011
    Date of Event
    September 23, 2009
    Report Date
    October 27, 2009
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K981095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    TREATING DOCTOR REPORTED THAT THE FIRST ALIGNERS WERE DELIVERED ON (B)(6) 2009 AND THEN ON (B)(6) 2009. THE PT REPORTED SWELLING ON HER LIPS AND SOME BREATHING ISSUES. THE DOCTOR ASKED THE PT TO REMOVE HER ALIGNERS IMMEDIATELY (WHICH THE PT DID). ONE DAY LATER, THE PT DISCONTINUED TREATMENT BECAUSE HER SYMPTOMS GOT WORSE AND HER HUSBAND TOOK HER TO THE ER FOR EVAL. ON (B)(6) 2009, THE PT RECEIVED MEDICAL ATTENTION AND WAS GIVEN MEDICATION, AND LEFT THE ER IN GOOD HEALTH. CURRENTLY, THE PT IS DOING WELL AND HER HEALTH IS COMPLETELY BACK TO HER NORMAL STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN ASSIST 5718261

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention