BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 4886333 · Received July 1, 2015

    Report

    Report Number
    2953749-2015-00438
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 30, 2015
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ALIGNERS ARE NOT BEING EVALUATED AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECIFICATIONS AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN SYSTEM ALIGNERS CAUSED OR CONTRIBUTED TO THE PATIENT SYMPTOMS. THIS EVENT IS BEING FILED AS AN MDR SINCE THE TREATING DOCTOR CONSIDERED THE EVENT WAS SERIOUS AND LIFE THREATENING TO THE PATIENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE SYMPTOMS OF DIFFICULTY BREATHING, DRY AND BUSTED LIPS, RASH ON MUCOUS MEMBRANE, ITCHY AND IRRITATED THROAT, SENSATION OF THROAT CLOSING AND SORE LIPS, GUMS AND TONGUE. THE PATIENT REPORTED VISITING A DERMATOLOGIST DUE TO THE REPORTED SYMPTOMS. THE PATIENT DID NOT REPORT TAKING OR BEING PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2015 AND THE PATIENT IS CURRENTLY FINE. THE TREATING DOCTOR CONSIDERED THE EVENT WAS SERIOUS AND LIFE THREATENING TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426865 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS NXC ALIGN TECHNOLOGY, INC. INVISAIGN LIGHT 15831530

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other