BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARRIERE MOTION 3D COLORS CLASS II

    MDR report key: 13553264 · Received February 17, 2022

    Report

    Report Number
    2081322-2022-00002
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Report Date
    February 17, 2022
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    EJF
    UDI-DI
    00190707032715
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER A ROUND OF ROUTINE POST-MARKET BIOCOMPATIBILITY STUDIES, ORTHO ORGANIZERS BECAME AWARE THAT A SAMPLE OF CARRIERE MOTION 3D COLORS CLASS II (GOLD) APPLIANCES HAD FAILED BIOCOMPATIBILITY (IRRITATION) TESTING. THE ORGANIZATION WILL BE CONDUCTING AN INVESTIGATION UNDER AN INTERNAL CAPA. HOWEVER, THE FULL TEST REPORT AND LABORATORY DATA HAVE NOT YET BEEN MADE AVAILABLE BY THE TESTING LABORATORY. THE INTERNAL INVESTIGATION WILL COMMENCE UPON RECEIPT OF THE FULL TEST REPORT DETAILING THE FAILURE.

    Description of Event or Problem · 0

    AFTER A ROUND OF ROUTINE POST-MARKET BIOCOMPATIBILITY STUDIES, ORTHO ORGANIZERS BECAME AWARE THAT THE MOTION 3D CLASS II COLORS (GOLD) APPLIANCE HAD FAILED BIOCOMPATIBILITY (IRRITATION) TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5745 CARRIERE MOTION 3D COLORS CLASS II ORTHODONTIC APPLIANCE EJF ORTHO ORGANIZERS, INC. 425-425R 00190707032715

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other