BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 3916308 · Received June 6, 2014

    Report

    Report Number
    2953749-2014-00227
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 25, 2014
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PATIENT REPORTED THE SYMPTOMS OF BREATHING DIFFICULTY, THROAT SWELLING AND BIG ULCERS. THE TREATING DOCTOR CONSIDERS THE EVENT WAS SERIOUS AND LIFE THREATENING TO THE PATIENT. BASED ON THE INFORMATION RECORDED THIS INCIDENT IS BEING REPORTED AS AN MDR.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THE SYMPTOMS OF BREATHING DIFFICULTY, THROAT SWELLING AND BIG ULCERS. THE PATIENT HAS REPORTED REGULARLY TAKING MEDICATION (UNSPECIFIED). THE PATIENT DID NOT REPORT REQUIRING ANY MEDICAL INTERVENTION DUE TO THE REPORTED SYMPTOMS. THE PATIENT REPORTED BEING PRESCRIBED CORTICOIDS DUE TO THE REPORTED SYMPTOMS. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2014 AND THE PATIENT IS CURRENTLY BETTER. THE TREATING DOCTOR CONSIDERS THE EVENT WAS SERIOUS AND LIFE THREATENING TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331407 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 12640017

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other