MAUDE Adverse Event Report: SWIFT HEALTH SYSTEMS INC. INBRACE; BRACKET, METAL, ORTHODONTIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Speech Disorder (4415)

Event Date 07/02/2019

Event Type  Injury  

Event Description

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).

• Brand Name: INBRACE
• Type of Device: BRACKET, METAL, ORTHODONTIC
• Manufacturer (Section D): SWIFT HEALTH SYSTEMS INC.
• MDR Report Key: 11027384
• MDR Text Key: 222369118
• Report Number: MW5098419
• Device Sequence Number: 1
• Product Code: EJF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR