BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2519776 · Received March 29, 2012

    Report

    Report Number
    2953749-2012-00080
    Event Type
    Other
    Date Received
    March 29, 2012
    Date of Event
    February 24, 2012
    Report Date
    March 14, 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 SPECIFICATIONS AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS. THE EVENT IS BEING FILED AS AN MDR, BECAUSE OF THE FACT THAT 'EPINEPHRINE' WAS PRESCRIBED AND THE ACTIONS TAKEN BY THE PATIENT, TO ALLEVIATE THE REPORTED SYMPTOMS APPEAR TO BE POTENTIALLY SERIOUS IN NATURE. NO EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN PRODUCT CAUSED OR CONTRIBUTED TO THE PATIENT SYMPTOMS.

    Description of Event or Problem · 1

    THE PATIENT STARTED THE TREATMENT ON (B)(6) 2012. THE PATIENT REPORTED THE SYMPTOMS OF BURNING SENSATION, WITH RASH, HIVES, AND ITCHING ON DIFFERENT PARTS OF THE BODY, INCLUDING (ARMS, LEGS, CHEST AND STOMACH). THE PATIENT INDICATED VISITING A GENERAL PHYSICIAN, WHO PRESCRIBED EPINEPHRINE (A HORMONE AND NEUROTRANSMITTER) INJECTION AND STEROIDS TO ALLEVIATE THE REPORTED SYMPTOMS. THE PATIENT WAS REFERRED TO AN ALLERGIST, BUT NO ADDITIONAL INFORMATION 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 TEEN 95366901

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other