BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 8108627 · Received November 27, 2018

    Report

    Report Number
    2953749-2018-02021
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    October 1, 2018
    Report Date
    November 27, 2018
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K181739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW UP REPORT TO 2953749-2018-02021 A CORRECTION WAS MADE TO THE DATE THE EVENT WAS RECEIVED BY ALIGN TECHNOLOGY, INC. THE DATE THIS EVENT WAS RECEIVED WAS OCTOBER 30, 2018 AND NOT OCTOBER 31, 2018.

    Description of Event or Problem · 0

    THIS IS A FOLLOW UP REPORT TO 2953749-2018-02021 A CORRECTION WAS MADE TO THE DATE THE EVENT WAS RECEIVED BY ALIGN TECHNOLOGY, INC. THE DATE THIS EVENT WAS RECEIVED WAS OCTOBER 30, 2018 AND NOT OCTOBER 31, 2018.

    Additional Manufacturer Narrative · 1

    NO CONCLUSIVE EVIDENCE HAS BEEN PROVIDED THAT SUPPORTS OR OPPOSES THAT FACT THAT THE INVISALIGN SYSTEM ALIGNERS CAUSED OR CONTRIBUTED TO THE PATIENTS SYMPTOMS. THIS EVENT IS BEING FILED AS AN MDR AS THIS EVENT APPEARS TO HAVE BEEN SERIOUS IN NATURE OR POTENTIALLY LIFE THREATENING TO THE PATIENT, AND AN INVISALIGN PRODUCT WAS BEING USED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SYMPTOMS OF SWOLLEN THROAT, DIFFICULTY BREATHING AND DIFFICULTY SWALLOWING. THE PATIENT REPORTED BEING TRANSPORTED TO THE ER (VIA AMBULANCE) AND WAS SEEN BY A CARDIOLOGIST AND A PHYSICIAN TO ALLEVIATE THE REPORTED SYMPTOMS. IT IS UNKNOWN IF THE PATIENT TOOK OR WAS PRESCRIBED ANY MEDICATION TO ALLEVIATE THE REPORTED SYMPTOMS. THE TREATMENT WAS DISCONTINUED ON (B)(6) 2018 AND THE PATIENT IS CURRENTLY ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947696 INVISALIGN SYSTEM SEQUENTIAL ALIGNER NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 26586587

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening