BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 2994498 · Received March 5, 2013

    Report

    Report Number
    2953749-2013-00042
    Event Type
    Other
    Date Received
    March 5, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K081960
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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, CONCLUSION) AND THE DEVICE WAS USED IN ACCORDANCE WITH LABELED INDICATIONS (RESULTS). THIS EVENT IS BEING REPORTED SINCE IT IS OUR OPINION THAT THE DIFFICULTY IS BREATHING, AND FLUID IN THE LUNGS, IS POTENTIALLY SERIOUS IN NATURE AND POTENTIALLY LIFE THREATENING TO THE PT IF LEFT UNTREATED, ALTHOUGH THE TREATING DOCTOR DOES NOT CONSIDER THE EVENT TO BE SERIOUS IN NATURE OR LIFE-THREATENING. NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THE FACT THAT THE INVISALIGN PRODUCT CAUSED OR CONTRIBUTED TO THE PT SYMPTOMS. SINCE THE INVISALIGN PRODUCT WAS BEING USED AT THE TIME OF THE REPORTED SYMPTOMS, AN MDR IS BEING FILED.

    Description of Event or Problem · 1

    THE PT REPORTED THE SYMPTOMS OF A SORE THROAT, BODY IRRITATION (REDNESS), DIFFICULTY BREATHING AND FLUID IN HER LUNGS. THE PT INDICATED VISITING THE EMERGENCY ROOM (ER). THE PT REPORTED TAKING 'BENADRYL' (OVER-THE-COUNTER, ANTIHISTAMINE), AND WAS PRESCRIBED AND PROVIDED AN EPIPEN (EPINEPHRINE INJECTION), BUT THE PT DID NOT USE IT. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93561 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN EXPRESS 7835971

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other