MAUDE Adverse Event Report: QUIETLAB ANTI-SNORING MOUTHPIECE; DEVICE, ANTI-SNORING

Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
I believe that this product is being sold without certification and is not effective in use.I also believe that the product could potentially lead to damaging teeth alignment over time based on my limited use.

• Brand Name: ANTI-SNORING MOUTHPIECE
• Common Device Name: DEVICE, ANTI-SNORING
• Manufacturer (Section D): QUIETLAB
• MDR Report Key: 21422274
• Report Number: MW5166547
• Device Sequence Number: 4135087
• Product Code: LRK
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2025
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White