MAUDE Adverse Event Report: ORMCO DENTAL BRACES; ORTHODONTIC BRACKETS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/31/2014

Event Type  Injury  

Event Description

I had braces, and it is very bad effect to my body health and mental health.It destroys my teeth that my teeth and gum looks very ugly.It made me mentally very unstable, and can not study, concentrate, and live by myself.I can not do what i can do before like go to school or eat.The dental braces totally destroyed my healthy life.Can not go to school or study.Very hard to communicate to someone due to destructive mental health.Dates of use: (b)(6) 2014 - (b)(6) 2015.

• Brand Name: DENTAL BRACES
• Type of Device: ORTHODONTIC BRACKETS
• Manufacturer (Section D): ORMCO
• MDR Report Key: 6995803
• MDR Text Key: 90974628
• Report Number: MW5073087
• Device Sequence Number: 1
• Product Code: EJF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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): Disability
• Patient Age: 23 YR