BEUDAMED
    FDA Adverse Event Other Summary report: N

    INVISALIGN SYSTEM

    MDR report key: 1993323 · Received February 7, 2011

    Report

    Report Number
    2953749-2011-00015
    Event Type
    Other
    Date Received
    February 7, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 4, 2011
    Manufacturer
    ALIGN TECHNOLOGY, INC.
    Product Code
    NXC
    PMA / PMN Number
    K981095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PT STARTED ALIGNER TREATMENTS ON (B)(6) 2011. ON (B)(6) 2011, THE PT REPORTED SYMPTOMS OF SWOLLEN LIPS AND INNER CHEEKS. THE PT TOOK BENADRYL AND REMOVED THE ALIGNERS, THE SYMPTOMS IMPROVED. THE PT RE-INSERTED THE ALIGNERS THE NEXT DAY AND THE SYMPTOMS RE-APPEARED. THE TREATING PHYSICIAN RECOMMENDED THE PT TO STOP TREATMENTS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISALIGN SYSTEM SEQUENTIAL ALIGNERS - ORTHODONTIC DEVICE NXC ALIGN TECHNOLOGY, INC. INVISALIGN FULL 80168021

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other