BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOBRACE

    MDR report key: 7742847 · Received August 1, 2018

    Report

    Report Number
    MW5078801
    Event Type
    Malfunction
    Date Received
    August 1, 2018
    Date of Event
    June 19, 2018
    Report Date
    July 30, 2018
    Manufacturer
    MYOFUNCTIONAL RESEARCH COMPANY USA, INC.
    Product Code
    DYJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY CHILD USED AN ORAL DENTAL DEVICE FROM MYOFUNCTIONAL RESEARCH COMPANY. THIS COMPANY IS LOCATED AT (B)(6). THE DEVICE IS KNOWN AS THE "MYOBRACE" "K1" FOR CHILDREN AGES 5-10. THE ORAL DEVICE DISINTEGRATES IN THE MOUTH AFTER 2-3 WEEKS OF USE. THE DENTAL OFFICE REPLACED IT WITH A NEW "K1." IT HAD THE SAME PROBLEM AGAIN. THEY THEN SWITCHED MY CHILD TO A "K2." AFTER A WEEK OF USAGE, I NOTICED MOLD DEVELOPING ON THE INSIDE OF THE ORAL DEVICE. MY DENTAL OFFICE INFORMED ME THAT I SHOULD RETURN THE MYOBRACE BACK TO THE DENTAL OFFICE. THE DENTIST THEN RETURNED THE "K2" TO MYOFUNCTIONAL RESEARCH COMPANY. THE DENTIST SAID THAT MYOFUNCTIONAL WAS TO EVALUATE THE APPLIANCE AND TEST IT TO SEE WHAT THE PROBLEM IS. MY DENTIST STILL HASN'T HEARD BACK FROM MYOFUNCTIONAL RESEARCH COMPANY. I CALLED THE MANUFACTURER AND SPOKE TO A LADY BY THE NAME OF (B)(6). SHE WAS NOT HELPFUL. TOLD ME THAT MY CHILD WAS NOT CLEANING IT PROPERLY. VERY POOR SUPPORT FROM MYOFUNCTIONAL RESEARCH COMPANY. PLEASE CONTACT THEM. PLEASE TAKE A LOOK AT THIS COMPANY. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580149 MYOBRACE RETAINER, SCREW EXPANSION, ORTHODONTIC DYJ MYOFUNCTIONAL RESEARCH COMPANY USA, INC.
    580150 MYOBRACE RETAINER, SCREW EXPANSION, ORTHODONTIC DYJ MYOFUNCTIONAL RESEARCH COMPANY USA, INC.
    580151 MYOBRACE RETAINER, SCREW EXPANSION, ORTHODONTIC DYJ MYOFUNCTIONAL RESEARCH COMPANY USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    0 8 YR