BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN

    MDR report key: 7731208 · Received July 27, 2018

    Report

    Report Number
    MW5078682
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    July 23, 2018
    Report Date
    July 26, 2018
    Manufacturer
    ALIGN TECHNOLOGY INC.
    Product Code
    ECQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FIRST TIME OF INVISALIGN. WITHIN HOURS OF INSERTION OF MY 1ST TRAY BY MY ORTHODONTIST, I HAD A BAD ADVERSE REACTION. SWOLLEN, BURNING AND TINGLING OF THROAT, TONGUE, SOFT PALATE AND LIPS. FELT LIKE THROAT WAS CLOSING. DIFFICULTY SWALLOWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568476 INVISALIGN ALIGNER ECQ ALIGN TECHNOLOGY INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Disability