BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 1961702 · Received January 11, 2011

    Report

    Report Number
    2953749-2009-00137
    Event Type
    Other
    Date Received
    January 11, 2011
    Date of Event
    December 21, 2009
    Report Date
    December 21, 2009
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K981095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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'S HUSBAND REPORTED THAT THE PT WAS EXPERIENCING BREATHING PROBLEMS SOON AFTER WEARING THE ALIGNERS. THE PT WENT TO THE HOSP AND WAS PLACED ON MEDICATION (VENTOLIN, TULMOCORT AND PROVENZON). THE PT HAD BEEN WEARING THE ALIGNER FOR LESS THAN TWO WEEKS. THE MSDS SHEET WAS PROVIDED TO THE PT AND HER GENERAL MEDICAL PHYSICIAN AND HE PROVIDED CLEARANCE TO RE-START TREATMENT SINCE NOTHING ON THE MSDS SHEET INCLUDED WHAT SHE IS ALLERGIC TO. THE PT HAS SINCE THEN DISCONTINUED TREATMENT. THE PT SAW A RESPIRATORY SPECIALIST AND IS STILL UNDERGOING TESTING AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 55672550

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention