MAUDE Adverse Event Report: UNKNOWN DEVICE, ANTI-SNORING

Device Problem Use of Device Problem (1670)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/01/2023

Event Type  Injury  

Event Description

I had a dental device made to help with snoring.Worn at night only.Wearing it caused my tmj to "click" while closing my mouth from an open position.I'm being sent to an oral surgeon for evaluation.

• Brand Name: DEVICE, ANTI-SNORING
• Type of Device: DEVICE, ANTI-SNORING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 16684186
• MDR Text Key: 312935401
• Report Number: MW5116368
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• 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: 04/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LEVOTHYROXINE, SIMVASTATIN, ESCITALOPRAM, ESTRADIOL, METHOTREXATE.; VIT D, PRESERVISION, FOLATE.
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White