MAUDE Adverse Event Report: THE DOCTOR'S NIGHTGUARD

Health Effect - Clinical Codes	Discomfort (2330); Difficulty Chewing (2670); No Code Available (3191)
Date of Event	02/01/2012
Type of Reportable Event	Serious Injury
Event or Problem Description
Just shortly after using the nightguard (which was molded properly as per the instructions) nightly for a few weeks, i developed an open bite, in which i could no longer touch my front teeth together, making chewing difficult and causing overall discomfort.I had to pay a lot of money to fix the open bite with braces.

• Brand Name: THE DOCTOR'S NIGHTGUARD
• Common Device Name: NIGHTGUARD
• MDR Report Key: 6158039
• Report Number: MW5066615
• Device Sequence Number: 17800423
• Product Code: MQC
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/07/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OTC MEDS: NONE. ; RX MEDS: NONE.
• Outcome Attributed to Adverse Event: Disability
• Patient Age: 18 YR
• Patient Weight: 50