BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARRIERE

    MDR report key: 10693781 · Received October 16, 2020

    Report

    Report Number
    2081322-2019-00001
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    October 11, 2019
    Report Date
    October 11, 2019
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    EJF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REQUESTED LOT NUMBER AND/OR FOR THE DEVICE TO BE RETURNED FOR EVALUATION, BUT NEITHER WAS RECEIVED.

    Description of Event or Problem · 1

    UPON REMOVAL OF ORTHODONTIC APPLIANCE, ENAMEL OF TOOTH NUMBER UL3 WAS DAMAGED. PER THE ORTHODONTIST, PATIENT WILL NEED A RESTORATION DONE BY HER DENTIST UPON COMPLETION OF ORTHODONTIC TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155896 CARRIERE MOTION 3D COLORS CLASS II 25MM LEFT SILVER EJF ORTHO ORGANIZERS, INC. 424-925LN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention