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

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

Patient Problems Irritation (1941); Pain (1994); Red Eye(s) (2038); Skin Irritation (2076); Swelling (2091)

Event Date 04/24/2020

Event Type  Injury  

Event Description

I purchased a sleep 8 cpap disinfecting system on (b)(6) 2020 from (b)(6).I used the product but it produced a strong odor.I followed the instruction to help remove the odor but the odor persisted.After several nights of use, i had skin irritation.My nose became red, painful and created water blisters.My eyes were irritated and i had respiratory problems.I sent (b)(6) an email about my concerns and i am still waiting for their reply.Fda safety report id# (b)(4).

• Brand Name: SLEEP 8
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SLEEP 8, INC.
• MDR Report Key: 10016997
• MDR Text Key: 189713415
• Report Number: MW5094332
• 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: 04/28/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 56 YR
• Patient Weight: 73