BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 5010245 · Received August 14, 2015

    Report

    Report Number
    2953749-2015-00548
    Event Type
    Injury
    Date Received
    August 14, 2015
    Date of Event
    July 1, 2015
    Report Date
    August 14, 2015
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT REPORTED SYMPTOMS OF ITCHY THROAT, SORE THROAT AND HIVES ALL OVER THE BODY. THE PT REPORTED VISITING THE ER DUE TO THE REPORTED SYMPTOMS. THE PT REPORTED BEING PRESCRIBED PREDNISONE (STEROID) AND STEROIDS (UNSPECIFIED) TO ALLEVIATE THE REPORTED SYMPTOMS. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2015. THE TREATING DOCTOR CONSIDERED THE EVENT WAS SERIOUS AND LIFE THREATENING TO THE PT DUE TO THE SEVERITY OF THE SYMPTOMS AND THE ER VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539997 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS NXC ALIGN TECHNOLOGY, INC. INVISALIGN TEEN 17008434

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other