MAUDE Adverse Event Report: THE DOCTOR'S NIGHTGUARD

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Discomfort (2330); Difficulty Chewing (2670); No Code Available (3191)

Event Date 02/01/2012

Event Type  Injury  

Event 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
• Type of Device: NIGHTGUARD
• MDR Report Key: 6158039
• MDR Text Key: 62103177
• Report Number: MW5066615
• Device Sequence Number: 1
• Product Code: MQC
• 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: 12/07/2016

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: OTC MEDS: NONE. ; RX MEDS: NONE.
• Patient Outcome(s): Disability
• Patient Age: 18 YR
• Patient Weight: 50