BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN

    MDR report key: 6950936 · Received October 13, 2017

    Report

    Report Number
    MW5072754
    Event Type
    Injury
    Date Received
    October 13, 2017
    Date of Event
    July 1, 2017
    Report Date
    October 11, 2017
    Manufacturer
    ALIGN TECHNOLOGY
    Product Code
    DYT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    STARTED INVISALIGN DENTAL CORRECTION IN (B)(6) 2017 AND DEVELOPED SIDE EFFECTS OF BURNING TONGUE, SWOLLEN FACE, BLOODY NOSE, RED EYES AND EXTREME FATIGUE. GOT WORSE THE LONGER I WORE THE RETAINERS. TOOK A FOUR WEEK BREAK AND WITHIN A WEEK ALL SYMPTOMS WERE GONE. INITIATED TREATMENT AGAIN WEARING THE RETAINER IN A "HYPOALLERGENIC" FORMULA AND SYMPTOMS WERE BACK IMMEDIATELY. ALIGN TECHNOLOGY IS THE MANUFACTURING COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729769 INVISALIGN MANITAINER, SPACE PERFORMED, ORTHODONTIC DYT ALIGN TECHNOLOGY

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR