BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 3199563 · Received June 26, 2013

    Report

    Report Number
    2953749-2013-00161
    Event Type
    Other
    Date Received
    June 26, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ALIGN TECHNOLOGY, INC
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AN MDR, BECAUSE THE ER DOCTORS CONFIRMED THAT THE PT HAD AN EPISODE OF ANAPHYLACTIC SHOCK. THE PT INDICATED VISITING THE E.R., AND BEING PRESCRIBED EPINEPHRINE. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN PRODUCT CAUSED OR CONTRIBUTED TO THE PT SYMPTOMS. BASED ON THE E.R. DOCTOR'S OPINION OF THE POTENTIAL ANAPHYLACTIC EPISODE AND 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 TREATMENT STARTED ON (B)(6) 2013. THE SYMPTOMS REPORTED BY THE PT WERE SWOLLEN LIPS, TONGUE AND CHEEKS, HIVES ALL OVER HER BODY, HYPERVENTILATION, AN EPISODE OF UNCONSCIOUSNESS AND AN E.R. CONFIRMATION OF ANAPHYLACTIC SHOCK. THE PT REPORTED VISITING THE E.R. AND BEING PRESCRIBED EPINEPHRINE, ZYRTEC (ANTIHISTAMINE) AND PREDNISONE (STEROID) TO ALLEVIATE THE REPORTED SYMPTOMS BY THE E.R. DOCTORS. NO ADDITIONAL INFO OR REPORTS WERE PROVIDED. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290577 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC INVISALIGN FULL 9801114

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other