BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 1981386 · Received January 13, 2011

    Report

    Report Number
    2953749-2011-00005
    Event Type
    Other
    Date Received
    January 13, 2011
    Date of Event
    November 11, 2010
    Report Date
    January 6, 2011
    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

    Description of Event or Problem · 1

    PT STARTED TREATMENT ON (B)(6) 2010. ON (B)(6) 2010, THE PT REPORTED REDNESS AND SPOTS ON THE OUTSIDE OF HER LIPS AND UNDER HER NOSE, ALL AROUND HER MOUTH. PT WENT TO A DERMATOLOGIST, AND WAS DIAGNOSED WITH MALIGN MELANOMA, BUT CONTINUED USING THE ALIGNERS. THE DERMATOLOGIST PRESCRIBED ANTIBIOTICS. ON (B)(6) 2011, THE PT STOPPED USING THE ALIGNERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC INVISALIGN FULL 71433647

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other