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

Model Number SLP82043

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Caustic/Chemical Burns (2549)

Event Date 05/20/2020

Event Type  Injury  

Event Description

I had purchased a sleep8 machine to clean my sleep apnea equipment.I was left with what i think are ozone burns on my face where my sleep apnea mask touched my face.This also happened back in april with burns on my nose, but these cleared up rather quickly.The places on my face have not cleared up, and it has been 3 weeks since the last incident.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: 10148176
• MDR Text Key: 195105558
• Report Number: MW5094960
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• 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 Age: 68 YR
• Patient Weight: 77