BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2474254 · Received February 28, 2012

    Report

    Report Number
    2953749-2012-00050
    Event Type
    Other
    Date Received
    February 28, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    ALIGN TECHNOLOGY INC
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALIGNERS ARE NOT BEING EVALUATED (METHOD) AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECS (RESULTS, CONCLUSION) AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS (RESULTS). THIS EVENT IS BEING FILED AS AN MDR, BECAUSE THE PT INDICATED VISITING THE ER AND THE ER DOCTORS FELT THE PT WAS SUFFERING FROM A TYPE OF ANAPHYLACTIC REACTION. NO ADD'L REPORTS WERE PROVIDED. NO EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES, THE FACT THAT THE INVISALIGN PRODUCT CAUSED OR CONTRIBUTED TO THE PT SYMPTOMS. BASED ON THE ER DOCTOR'S OPINION OF THE POTENTIAL ANAPHYLACTIC EPISODE, AND SINCE INVISALIGN PRODUCT WAS BEING USED AT THE TIME OF THE REPORTED SYMPTOMS, A MDR IS BEING FILED.

    Description of Event or Problem · 1

    THE TREATMENT STARTED ON (B)(6) 2012. THE PT REPORTED THE SYMPTOMS OF SWOLLEN HANDS, FEET, TONGUE AND LIPS, HIVES ON THE PT'S FACE THAT PROGRESSIVELY EXTENDED TO THE WHOLE BODY, AND BREATHING DIFFICULTIES. THE PT INDICATED VISITING THE ER (ER) ON (B)(6) 2012. THE ER DOCTORS FELT THAT THE PT WAS SUFFERING FROM A TYPE OF ANAPHYLACTIC REACTION, BUT NO ADD'L REPORTS WERE PROVIDED. THE PT DISCONTINUED THE TREATMENT ON (B)(6) 2012. THIS EVENT IS CONSIDERED TO BE POTENTIALLY SERIOUS IN NATURE OR LIFE-THREATENING TO THE PT DUE TO POSSIBILITY OF THIS EVENT BEING AN ANAPHYLACTIC EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY INC INVISALIGN FULL 4213941

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other