BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 5019765 · Received August 20, 2015

    Report

    Report Number
    2953749-2015-00607
    Event Type
    Injury
    Date Received
    August 20, 2015
    Date of Event
    August 2, 2015
    Report Date
    August 20, 2015
    Manufacturer
    ALIGN TECHNOLOGY, INC
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO TEST METHODS HAVE BEEN PERFORMED 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 IS BEING FILED AS AN MDR SINCE THE PATIENT WAS HOSPITALIZED AND INVISALIGN SYSTEM PRODUCT WAS BEING USED AT THAT TIME. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SYMPTOMS OF ANAPHYLACTIC SHOCK AND DIFFICULTY BREATHING. THE PATIENT REPORTED VISITING THE EMERGENCY ROOM AND WAS HOSPITALIZED FOR TWO DAYS DUE TO THE REPORTED SYMPTOMS. THE PATIENT REPORTED TAKING BENADRYL (OVER-THE-COUNTER, ANTIHISTAMINE) TO ALLEVIATE THE REPORTED SYMPTOMS (IT IS UNKNOWN IF THE PATIENT WAS PRESCRIBED ANY MEDICATION AT THE ER). THE TREATMENT WAS DISCONTINUED ON (B)(6) 2015 AND THE PATIENT IS CURRENTLY BACK TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552035 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS NXC ALIGN TECHNOLOGY, INC INVISALIGN TEEN 17148463

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| O