BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISIBLE DENTAL ALIGNERS

    MDR report key: 7999768 · Received October 23, 2018

    Report

    Report Number
    MW5080781
    Event Type
    Injury
    Date Received
    October 23, 2018
    Report Date
    October 22, 2018
    Manufacturer
    SMILEDIRECTCLUB, LLC
    Product Code
    NXC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER USING SMILE DIRECT CLUB INVISIBLE ALIGNERS, I STARTED EXPERIENCING EPISODES OF BREATHLESSNESS, SEVERE CHEST PAIN AND FEELING OF A LUMP IN MY THROAT. I WENT TO THE ER TWICE AND OUTPATIENT TWICE. AT THE TIME I DID NOT KNOW IT WAS RELATED TO THE ALIGNERS, SO I'M NOT SURE IF ANY OF THE TESTING DONE CAN PROVE IT WAS THE ALIGNERS. AFTER SPEAKING WITH THE COMPANY, I STOPPED TREATMENT UNTIL SYMPTOMS SUBSIDED AND THEN STARTED AGAIN. THE SYMPTOMS WERE BACK AND WORSE, THAT'S WHEN I FOUND OUT IT WAS THE ALIGNERS. THE COMPANY THEN OFFERED A FULL REFUND ONLY IF I SIGNED THEIR RELEASE WHICH BASICALLY MEANT THAT I WOULD SIGN ALL MY RIGHTS AWAY, I DID NOT SIGN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838718 INVISIBLE DENTAL ALIGNERS ALIGNER, SEQUENTIAL NXC SMILEDIRECTCLUB, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other