BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN RETAINER

    MDR report key: 21027173 · Received December 26, 2024

    Report

    Report Number
    MW5163996
    Event Type
    Injury
    Date Received
    December 26, 2024
    Date of Event
    December 17, 2024
    Report Date
    December 20, 2024
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    DYT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD A DENTIST PUT IN THE INVISALIGN DOTS/RETAINERS FOR ME ON (B)(6) 2024. I STARTED WEARING THE RETAINERS ON A DAILY BASIS STARTING (B)(6) 2024. I TASTED PLASTIC LEECHING IN MY MOUTH BUT DIDN'T THINK ANYTHING OF IT AT FIRST. I STARTED TO NOTICE THAT MY MOUTH WAS GETTING SENSITIVE AND STARTED DEVELOPING LESIONS AND MY THROAT WAS A LITTLE SORE. I CONTACTED THE DENTIST OFFICE ON (B)(6) TELLING THEM ABOUT MY SYMPTOMS AND THEY SAID IT WAS STANDARD. THEN I SENT THEM PICTURES ON (B)(6) OF MY SORES. BY MONDAY (B)(6) THE DENTIST HAD REACHED OUT TO INVISALIGN ABOUT THE ISSUE. BY MONDAY NIGHT MY THROAT WAS GETTING SWOLLEN AND THE LESIONS IN MY MOUTH WERE GETTING REALLY BAD I COULD HARDLY SWALLOW WATER OR FOOD THAT I TEXTED THE DENTIST OFFICE AT 1:24 AM TO LET THEM KNOW I NEEDED TO GET THE DOTS TAKEN OUT ASAP. I HAD TO TAKE BENADRYL TO REDUCE SOME OF THE TONGUE AND THROAT SWELLING BY TUESDAY MORNING AS I COULDN'T TALK PROPERLY AND FELT LIKE MY THROAT COULD CLOSE UP. I WENT BACK TO THE DENTIST OFFICE BY TUESDAY NIGHT TO GET THE DOTS TAKEN OUT. IN THE MIDST OF FILING DOWN AND REMOVAL OF THE DOTS, I THINK THE FILING CAUSE A TORNADO OF MICROPLASTICS TO SPRAY MY MOUTH AND THROAT. MY THROAT AND TONGUE SWELLED UP REALLY BADLY THAT NIGHT AND BENADRYL WASN'T HELPING AT THAT POINT. I COULD BARELY TALK. WEDNESDAY MORNING THE SWELLING CONTINUED BUT WAS NOT AS BAD. I HAVE NO DOUBT THAT THE RETAINERS CAUSED THE LESIONS IN MY MOUTH AND THE DOTS/ADHESIVES WERE CAUSING MY THROAT/TONGUE TO SWELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730177 INVISALIGN RETAINER MAINTAINER, SPACE PREFORMED, ORTHODONTIC DYT ALIGN TECHNOLOGY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Life Threatening| R