BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN

    MDR report key: 1467866 · Received September 4, 2009

    Report

    Report Number
    MW5012617
    Event Type
    Other
    Date Received
    September 4, 2009
    Date of Event
    September 4, 2009
    Report Date
    September 4, 2009
    Manufacturer
    INVISALIGN
    Product Code
    NXC
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN USING INVISALIGN BRACES SINCE LATE 2005, EARLY 2006. I HAVE BEEN HAVING PROBLEMS WITH MY BREATHING, LIKE I CAN"T CATCH MY BREATH. SOMETIMES, I FEEL LIKE I AM GASPING FOR AIR. I AM ALSO HAVING CHEST PAINS. I HAVE BEEN EXPERIENCING THESE PROBLEMS SINCE 2006, AND HAVE HAD A BUNCH OF TESTS FOR MY HEART AND CHEST. EVERYTHING CAME BACK FINE. I'M JUST STARTING TO THINK WHAT HAS CHANGED IN MY LIFE SINCE THESE SYMPTOMS HAVE OCCURRED, AND HAVE NOT GOTTEN BETTER. THE ONLY THING I AM THINKING IS THESE THINGS STARTED TO SURFACE A FEW MONTHS AFTER STARTING WITH MY INVISALIGN TREATMENTS. COULD THERE BE SOMETHING IN THE PLASTIC THAT IS CAUSING THIS? I WOULD REALLY LIKE TO KNOW WHAT THEY ARE MADE OF. I AM TOO YOUNG TO NOT BE ABLE TO BREATH NORMALLY. DOSE OR AMOUNT: NEW ALIGNER EVERY TWO WEEKS. DATES OF USE: STILL USING. DIAGNOSIS OR REASON FOR USE: STRAIGHTEN TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN INVISALIGN BRACES NXC INVISALIGN

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR