BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 15653257 · Received October 21, 2022

    Report

    Report Number
    2953749-2022-03307
    Event Type
    Injury
    Date Received
    October 21, 2022
    Date of Event
    October 17, 2022
    Report Date
    May 17, 2023
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    UDI-DI
    00816063020189
    PMA / PMN Number
    K220287
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CURRENT INSTRUCTIONS FOR USE (IFU) CONTAINS THE FOLLOWING; "WARNING - IN RARE INSTANCES, SOME PATIENTS MAY BE ALLERGIC TO THE PLASTIC ALIGNER MATERIAL, DISCONTINUE USE AND CONSULT A HEALTH CARE PROFESSIONAL IMMEDIATELY". THE TREATING DOCTOR SHARED THAT THE POTENTIAL ROOT CAUSE COULD BE AN ALLERGIC REACTION. THIS EVENT IS BEING FILED AS AN MDR SINCE THE PATIENT REPORTED ANGIOEDEMA, DIFFICULTY BREATHING AND TACHYCARDIA AND THE INVISALIGN PRODUCT WAS BEING USED.

    Additional Manufacturer Narrative · 0

    ALIGN TECHNOLOGY, INC. RECEIVED ADDITIONAL INFORMATION ABOUT THE TOXICOLOGY REPORT ON 11/17/2022. THIS INFORMATION WAS ADDED TO SECTION B6. THIS EVENT REMAINS A SERIOUS ADVERSE EVENT AND THE NEW INFORMATION DOES NOT CHANGE THE REPORTING DECISION IN THE UNITED STATES. B6: THE PATIENT BELIEVES THAT THE TRAYS HAVE CAUSED A TOXIC REACTION DUE TO THE TRAYS LEACHING MATERIAL. TOXICOLOGY PANEL RESULTS SHOWED HIGH LEVELS OF THE POLYURETHANE RESINS (THE SAME MATERIAL THE TRAYS ARE MADE OF) IN HER SYSTEM. THE CATALOG NUMBER OF THE TREATMENT OPTION WAS CORRECTED. D4: 9000.

    Description of Event or Problem · 0

    THE PATIENT REPORTED SYMPTOMS OF ANGIOEDEMA, DIFFICULTY BREATHING, INCREASES HEART RATE (201), TACHYCARDIA AND SWOLLEN LIPS. THE PATIENT REPORTED REQUIRING VISITING THE ER (3RD VISIT) DUE TO THE REPORTED SYMPTOMS. THE PATIENT REPORTED BEING PRESCRIBED BENADRYL, ZYRTEC / PREDNISONE (CORTICOSTEROIDS) BY PHYSICIAN TO ALLEVIATE REPORTED SYMPTOMS. THE PATIENT REPORTED DISCONTINUING THE USE OF THE ALIGNERS ON (B)(6) 2022, BUT THE CONDITION HAS NOT IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929141 INVISALIGN SYSTEM ALIGNER, SEQUENTIAL NXC ALIGN TECHNOLOGY, INC. INVISALIGN SYSTEM - COMPREHENSIVE 113405202 00816063020189

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Life Threatening| O