BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2845104 · Received November 6, 2012

    Report

    Report Number
    2953749-2012-00290
    Event Type
    Other
    Date Received
    November 6, 2012
    Date of Event
    October 29, 2012
    Report Date
    October 30, 2012
    Manufacturer
    ALIGN TECHNOLOGY, INC
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALIGNERS ARE NOT BEING EVALUATED AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECS AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS. THIS EVENT IS BEING REPORTED, BECAUSE THE TREATING DOCTOR CONSIDERED THE RESPIRATORY PROBLEMS MAY HAVE BEEN THE INDICATION OF ANAPHYLAXIS EPISODE. THE PT INDICATED VISITING AN ER, BUT NO DIAGNOSIS OR 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 TREATING DOCTOR'S OPINION OF THE POTENTIAL ANAPHYLAXIS 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 PT REPORTED THAT THE TREATMENT STARTED ON (B)(6) 2012. ON (B)(6) 2012, THE PT REPORTED THE SYMPTOMS OF SENSATION OF THROAT CLOSING, CHEST PAIN, SHORTNESS OF BREATH AND HIVES IN HER MOUTH. THE TREATING DOCTOR INDICATED THAT THE PT VISITED THE ER ON (B)(6) 2012, BUT NO DIAGNOSIS OR ADD'L REPORTS WERE PROVIDED. THE TREATMENT WAS DISCONTINUED (B)(6) 2012 AND THE SYMPTOMS DISAPPEARED. THE TREATING DOCTOR CONSIDERED THE REPORTED SYMPTOMS MAY HAVE BEEN AN INDICATION OF AN ANAPHYLAXIS EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC INVISALIGN EXPRESS 7593686

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other