BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBRACE

    MDR report key: 11027384 · Received December 16, 2020

    Report

    Report Number
    MW5098419
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    July 2, 2019
    Report Date
    December 14, 2020
    Manufacturer
    SWIFT HEALTH SYSTEMS INC.
    Product Code
    EJF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD THE BEHIND THE TEETH BRACES AKA ORTHODONTIC APPLIANCE BY INBRACE (WWW.INBRACE.COM) INSTALLED AND IT SEVERELY IMPACTED MY SPEECH, INCLUDING A HORRIBLE LISP. DESPITE NUMEROUS ADJUSTMENTS AND VARIOUS ATTEMPTS BY THE ORTHODONTIST (AND RECOMMENDATION OF AN ASSORTMENT OF EXERCISES TO RELEARN HOW TO PRONOUNCE WORDS) THEY WERE UNSUCCESSFUL. I HAD TO HAVE IT REMOVED AND WAS CHARGED A PENALTY OF $(B)(6). I HAVE REACHED OUT TO THE COMPANY NUMEROUS OCCASIONS INCLUDING THE CEO, NO ONE HAS RESPONDED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484333 INBRACE BRACKET, METAL, ORTHODONTIC EJF SWIFT HEALTH SYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention