BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL BRACES

    MDR report key: 6995803 · Received November 2, 2017

    Report

    Report Number
    MW5073087
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    January 31, 2014
    Report Date
    October 31, 2017
    Manufacturer
    ORMCO
    Product Code
    EJF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD BRACES, AND IT IS VERY BAD EFFECT TO MY BODY HEALTH AND MENTAL HEALTH. IT DESTROYS MY TEETH THAT MY TEETH AND GUM LOOKS VERY UGLY. IT MADE ME MENTALLY VERY UNSTABLE, AND CAN NOT STUDY, CONCENTRATE, AND LIVE BY MYSELF. I CAN NOT DO WHAT I CAN DO BEFORE LIKE GO TO SCHOOL OR EAT. THE DENTAL BRACES TOTALLY DESTROYED MY HEALTHY LIFE. CAN NOT GO TO SCHOOL OR STUDY. VERY HARD TO COMMUNICATE TO SOMEONE DUE TO DESTRUCTIVE MENTAL HEALTH. DATES OF USE: (B)(6) 2014 - (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776410 DENTAL BRACES ORTHODONTIC BRACKETS EJF ORMCO

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Disability