BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARA

    MDR report key: 18142166 · Received November 14, 2023

    Report

    Report Number
    MW5148152
    Event Type
    Injury
    Date Received
    November 14, 2023
    Date of Event
    June 8, 2023
    Report Date
    October 17, 2023
    Manufacturer
    UNK
    Product Code
    DYJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS PUT IN A FARA(FIXED ANTERIOR REMODELING APPLIANCE) DEVICE FOR EXPANSION FROM A DENTIST THAT SAID SHE SPECIALIZED IN TMJ SHE CONFIRMED I HAD TMJ ISSUES. AFTER WEARING IT FOR OVER 2 YEARS I NOTICED MY TEETH WERE GETTING IN BAD SHAPE. ASKED FOR IT TO BE REMOVED BY DENTIST AND THEY WOULD NOT. I WENT TO ORTHODONTICS AND PAID TO HAVE IT TAKEN OFF. I HAD TO HAVE 2 ROOT CANALS AND OTHER TEETH HAD TO HAVE LOTS OF FILLINGS TO REPAIR DAMAGE. BONE LOSS ALSO. I DIDN'T KNOW ANYTHING ABOUT REPORTING THIS UNTIL I WAS SEEING THE REPORTS ON ALL THE FIXED APPLIANCES LIKE THE AGGA. I WANT TO SAVE ANYONE ELSE FROM GETTING THIS TREATMENT FROM DENTIST THAT WERE TRAINED AT THE (B)(6) INSTITUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234533 FARA RETAINER, SCREW EXPANSION, ORTHODONTIC DYJ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female