MAUDE Adverse Event Report: SLEEP 8, INC. OZONE CPAP CLEANING MACHINE; DISINFECTANT, MEDICAL DEVICES

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Rash (2033)

Event Date 01/15/2022

Event Type  Injury  

Event Description

Skin rash on face; ozone cpap cleaning machine.Fda safety report id# (b)(4).

• Brand Name: OZONE CPAP CLEANING MACHINE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SLEEP 8, INC.
• MDR Report Key: 13500052
• MDR Text Key: 285415523
• Report Number: MW5107323
• 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: 02/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 46 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White