BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2449923 · Received February 10, 2012

    Report

    Report Number
    2953749-2012-00031
    Event Type
    Other
    Date Received
    February 10, 2012
    Date of Event
    January 8, 2012
    Report Date
    January 18, 2012
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ALIGNERS ARE NOT BEING EVALUATED (METHOD) AS THE PRODUCT PERFORMED IN ACCORDANCE TO SPECIFICATIONS (RESULTS AND CONCLUSION) AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS (RESULTS). THIS EVENT IS BEING FILED AS AN MDR, BECAUSE THE TREATING DOCTOR CONSIDERED THIS EVENT TO BE POTENTIALLY SERIOUS AND LIFE THREATENING TO THE PATIENT, DUE TO THE POTENTIAL THAT THE PATIENT MAY HAVE EXPERIENCED 'CONGESTIVE HEART FAILURE'. THE PATIENT INDICATED VISITING THE EMERGENCY ROOM, BUT NO ADDITIONAL INFORMATION (TEST OR LAB REPORTS) HAS BEEN PROVIDED. NO EVIDENCE HAS BEEN PROVIDED WHICH SUPPORTS OR OPPOSES, THAT THE PATIENT'S REPORTED SYMPTOMS WERE CAUSED OR CONTRIBUTED BY THE USE OF THE INVISALIGN PRODUCT. SINCE THE INVISALIGN PRODUCT WAS IN USE DURING THE REPORTED SYMPTOMS AND WHEN THE PATIENT SOUGHT ADDITIONAL MEDICAL TREATMENT, AN MDR IS BEING FILED.

    Description of Event or Problem · 1

    THE TREATMENT STARTED ON (B)(6) 2011. ON (B)(6) 2012, THE PATIENT DEVELOPED SYMPTOMS OF SEVERE SWOLLEN LEGS AND FEET, ITCHING (LOCATION UNKNOWN), AND FATIGUE. THE PATIENT INDICATED VISITING A 'CARDIOLOGIST' WHO THOUGHT THE PATIENT WAS HAVING A 'CONGESTIVE HEART FAILURE' (CHF) EVENT. THE PATIENT ALSO INDICATED VISITING THE EMERGENCY ROOM (ER) (DATE UNKNOWN), BUT NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2012, THE TREATMENT WAS DISCONTINUED AND THE SYMPTOMS DISAPPEARED. THE TREATING DOCTOR CONSIDERED THIS EVENT TO BE POTENTIALLY SERIOUS AND LIFE THREATENING TO THE PATIENT, DUE TO THE POTENTIAL THAT THE PATIENT MAY HAVE EXPERIENCED 'CONGESTIVE HEART FAILURE'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 96949535

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other