BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2823612 · Received November 2, 2012

    Report

    Report Number
    2953749-2012-00283
    Event Type
    Other
    Date Received
    November 2, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ALIGN TECHNOLOGY INC
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALIGNERS ARE NOT BEING EVALUATED AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECIFICATIONS AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS. THIS EVENT IS BEING REPORTED, AS THE PT VISITED THE ER AND WAS HOSPITALIZED FOR 3 DAYS. NO DIAGNOSIS, REPORTS OR ADDITIONAL INFO WAS PROVIDED. NO EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN PRODUCT CAUSED OR CONTRIBUTED TO THE PT'S SYMPTOMS. SINCE THE INVISALIGN PRODUCT WAS BEING USED AT THE TIME OF THE REPORTED SYMPTOMS, AN MDR IS BEING FILED.

    Description of Event or Problem · 1

    THE PT STARTED THE TREATMENT ON (B)(6) 2012. THE PT REPORTED SWOLLEN FACE AND LIPS. THE PT REPORTED VISITING THE EMERGENCY ROOM (ER) DUE TO THE REPORTED SYMPTOMS. THE PT ALSO INDICATED THAT SHE WAS HOSPITALIZED FOR 3 DAYS. THE PT WAS PRESCRIBED STEROIDS (NAMES UNSPECIFIED) TO ALLEVIATE THE REPORTED SYMPTOMS. THE PT ALSO INDICATED VISITING AN ALLERGIST, AND THE ALLERGIST RULED OUT POSSIBILITY OF FOOD ALLERGIES. NO DIAGNOSIS, REPORTS OR ADDITIONAL INFO WAS PROVIDED. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY INC INVISALIGN FULL 4329231

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other