BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 1961699 · Received January 11, 2011

    Report

    Report Number
    2953749-2009-00092
    Event Type
    Other
    Date Received
    January 11, 2011
    Date of Event
    June 19, 2009
    Report Date
    June 19, 2009
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K981095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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

    DR'S OFFICE REPORTED HIS PT, CLAIMED THAT SHE HAD A SORE THROAT WHEN THE ALIGNERS ARE IN HER MOUTH, AND WITH A BURNING SENSATION ON HER CHEST AND IN HER THROAT AND SHE ALSO FELT THE SENSATION THAT HER THROAT WAS CLOSING UP. THE DOCTOR TOOK THEM OUT, LET THE PT SIT FOR AN HR AND THE PT STATED THAT HER SORE THROAT WENT AWAY. THEN THE DOCTOR PLACED THEM BACK IN AND THE PT STATED THAT HER SORE THROAT WAS BACK. THE DOCTOR ADVISED THE PT NOT TO WEAR THE ALIGNER, AS SHE MAY HAVE AN ALLERGY TO THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 54998304

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention