MAUDE Adverse Event Report: APNEA SCIENCES CORPORATION SNOREMD MICRO-ADJUSTABLE SNORING MOUTHFUARD; DEVICE, ANTI-SNORING

Device Problem Use of Device Problem (1670)

Patient Problems Pain (1994); Burning Sensation (2146); Swelling/ Edema (4577)

Event Date 03/09/2023

Event Type  Injury  

Event Description

I purchased snoremd mouth guard to help with snoring.It did help with my snoring but after 4 or 5 days my lips were burning and swollen.I took care of it as directed so it wasn't anything i did.I quit wearing it for a week to heal my lips and tried to wear it again this week with lip balm but they are now burning again.I contacted the company and am waiting to hear back.It's an incredibly painful reaction to something they use in their product.

• Brand Name: SNOREMD MICRO-ADJUSTABLE SNORING MOUTHFUARD
• Type of Device: DEVICE, ANTI-SNORING
• Manufacturer (Section D): APNEA SCIENCES CORPORATION
• MDR Report Key: 16683518
• MDR Text Key: 312822352
• Report Number: MW5116313
• 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: 03/30/2023

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
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White