BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARRIERE MOTION 3D COLORS CLASS II 27MM RIGHT - SILVER

    MDR report key: 8124525 · Received December 3, 2018

    Report

    Report Number
    2081322-2018-00002
    Event Type
    Injury
    Date Received
    December 3, 2018
    Date of Event
    November 7, 2018
    Report Date
    November 19, 2018
    Manufacturer
    ORTHO ORGANIZERS, INC
    Product Code
    EJF
    UDI-DI
    00190707023447
    PMA / PMN Number
    510(K) EXEMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DENTIST PRESCRIBED DEBACTROL FOR "CANKER SORES" ON (B)(6). IT IS EXPECTED THAT THE PRESCRIBED MEDICATION WILL RESOLVE THE IRRITATION.

    Description of Event or Problem · 1

    PATIENT HAD DEVICE BONDED ON (B)(6) 2018. ON (B)(6), PATIENT PRESENTED TO DENTAL OFFICE WITH CANKER SORES. DEVICE WAS DEBONDED, AND DEBACTEROL TREATMENT WAS INITIATED BY DENTIST ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966093 CARRIERE MOTION 3D COLORS CLASS II 27MM RIGHT - SILVER METAL ORTHODONTIC BRACKET EJF ORTHO ORGANIZERS, INC 424-927RN 00190707023447

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other