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

Model Number SLP82043

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Skin Irritation (2076)

Event Date 11/01/2020

Event Type  Injury  

Event Description

Skin irritation around cpap; i have been using a cpap with a dream wear nasal pillow for about 1.5 years.I bought a (b)(6) brand ozone sanitizer to clean my mask, hose, and water chamber about 1 year ago.It consists of an ozone generator and sealable bag.At first, i sanitized my equipment every 3 days.I had no problems.About 4 months ago, i started sanitizing every day after reading the manufacturer of my cpap machine recommended daily cleaning.Within a couple of weeks i developed a persistent irritation around my nares.My doctor prescribed a cortisone cream that helps but since i continued daily sanitation, it has never cleared up.I stopped using the (b)(6) system about a week ago and began cleaning with soap and water, the irritation is slowly healing.I am fairly certain that the daily exposure to ozone caused the persistent irritation, itching, peeling, and scabby skin on my nose.I can continue to clean with soap and water but would prefer something more convenient.The hose is difficult to properly clean by hand.I would appreciate any recommendations.Fda safety report id# (b)(4).

• Brand Name: SLEEP8
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SLEEP 8, INC.
• MDR Report Key: 11372097
• MDR Text Key: 233514166
• Report Number: MW5099566
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 00860224002637
• UDI-Public: 860224002637
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 84