BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN

    MDR report key: 5053926 · Received August 28, 2015

    Report

    Report Number
    MW5055906
    Event Type
    Injury
    Date Received
    August 28, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 28, 2015
    Manufacturer
    ALIGN TECHNOLOGY INC.
    Product Code
    NXC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED INVISALIGN TO CORRECT MY SHIFTING TEETH. UPON INSERTING THE ALIGNERS, MY MOUTH IMMEDIATELY BEGAN TO HURT, AS WELL AS MY TONGUE. WITHIN 48 HOURS I DEVELOPED, NUMEROUS MOUTH ULCERS, SWOLLEN LIPS, TONGUE REDNESS AND IRRITATION, AS WELL AS SEVERE PAIN AND TENDERNESS THROUGHOUT MY MOUTH. UPON GOING TO MY DENTIST DUE TO THE INCREASED PAIN, I HAD TO HAVE THEM IMMEDIATELY REMOVED AS I DEVELOPED A SEVERE ALLERGIC REACTION TO THE MATERIAL IN THE ALIGNERS. WITHIN A DAY AND A HALF OF REMOVAL OF THE APPLIANCE, MY MOUTH ULCERS, IRRITATION AND PAIN HAD DISAPPEARED. I WAS TOLD BY MY DENTIST THAT INVISALIGN HAD CHANGED ITS MATERIAL OVER THE PAST 2 YEARS. I AM STILL WAITING TO HEAR BACK FROM THEM IF I AM ELIGIBLE FOR A REFUND, AS MY TOTAL EXPENSES INCURRED WERE (B)(6), FOR APPLIANCES THAT I CAN NOT TOLERATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572900 INVISALIGN INVISALIGN NXC ALIGN TECHNOLOGY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention