MYOBRACE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-01 for MYOBRACE manufactured by Myofunctional Research Company Usa, Inc..

Event Text Entries

[116047738] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5078801
• MDR Report Key: 7742847
• Date Received: 2018-08-01
• Date of Report: 2018-07-30
• Date of Event: 2018-06-19
• Date Added to Maude: 2018-08-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: MYOBRACE
• Generic Name: RETAINER, SCREW EXPANSION, ORTHODONTIC
• Product Code: DYJ
• Date Received: 2018-08-01
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MYOFUNCTIONAL RESEARCH COMPANY USA, INC.

Device Sequence Number: 2

• Brand Name: MYOBRACE
• Generic Name: RETAINER, SCREW EXPANSION, ORTHODONTIC
• Product Code: DYJ
• Date Received: 2018-08-01
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MYOFUNCTIONAL RESEARCH COMPANY USA, INC.

Device Sequence Number: 3

• Brand Name: MYOBRACE
• Generic Name: RETAINER, SCREW EXPANSION, ORTHODONTIC
• Product Code: DYJ
• Date Received: 2018-08-01
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: MYOFUNCTIONAL RESEARCH COMPANY USA, INC.

Patients

Patient Number	Treatment	Outcome	Date
0	0		2018-08-01