BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRACES (DAMON CERAMIC BRACES)

    MDR report key: 6993510 · Received November 1, 2017

    Report

    Report Number
    MW5073068
    Event Type
    Injury
    Date Received
    November 1, 2017
    Date of Event
    February 1, 2014
    Report Date
    October 28, 2017
    Manufacturer
    ORMCO CORPORATION
    Product Code
    NJM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD BRACES. I THOUGHT BRACES WAS SAFE, BUT IT TOTALLY MADE MY BITE BAD, AND MADE MY WHOLE TEETH ALIGNMENT LOOKS UGLY. I THINK IT MADE MY MIND SO UNSTABLE. CANNOT CONCENTRATE AT ALL. I WANT FDA TO BAN THE BRACES. IT IS DANGEROUS. IT STOLE THE HEALTHY LIFE FROM ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774208 BRACES (DAMON CERAMIC BRACES) ORTHODONTIC CERAMIC BRACKETS NJM ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR