MAUDE Adverse Event Report: SLEEP8, INC. SLEEP8 CPAP CLEANER; DISINFECTANT, MEDICAL DEVICES

Device Problem Device Emits Odor (1425)

Patient Problem Skin Burning Sensation (4540)

Event Date 07/12/2022

Event Type  Injury  

Event Description

I was using my cpap mask after using a sleep8 cleaning device.I woke up several hours later with extreme burning in my nostrils and sinuses, and a strong metallic type odor.I had to take the mask off and go outside to get fresh air.It took an hour or so for the burning sensation to subside.A day later, my sinuses are still irritated.Fda safety report id # (b)(4).

• Brand Name: SLEEP8 CPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SLEEP8, INC.
• MDR Report Key: 15043021
• MDR Text Key: 296137189
• Report Number: MW5110909
• Device Sequence Number: 1
• Product Code: LRJ
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• 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: FAMOTIDINE ; GARLIC; MAGNESIUM; PAPAYA ENZYME; RESMED CPAP MACHINE
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White