MAUDE Adverse Event Report: SLEEP 8, INC. SLEEP8; DISINFECTANT, MEDICAL DEVICES

Model Number SLP82043

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 05/07/2020

Event Type  Injury  

Event Description

Used product - sleep8 cpap cleaning device using ozone3 to disinfect cpap masks etc - for ten months.Then developed a skin rash on my face where mask made contact with my skin.Tried wiping cpap equipment down with cpap wipes after disinfection with sleep8 device.Rash got worse.Took a while for me to realize there might be such a thing as allergies to ozone3.Research on the internet turned up information confirming my hunch.Have stopped using machine.Further research revealed these devices do not carry an fda approval nor have they been patented.Residual problem - severe nasal allergy persists even without the use of the sleep 8 machine.Will consult with doctor asap regarding possible permanent damage to my respiratory system given my extended exposure to the ozone 3.Fda safety report id# (b)(4).

• Brand Name: SLEEP8
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SLEEP 8, INC.
• MDR Report Key: 10065058
• MDR Text Key: 191400402
• Report Number: MW5094527
• 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: 05/14/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SLP82043
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 89