MAUDE Adverse Event Report: NATURES PILLOWS, INC. AND TOP DOG DIRECT, LLC CLEANZONE; DISINFECTANT, MEDICAL DEVICES

Model Number S4 PLUS

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Erythema (1840); Pain (1994); Superficial (First Degree) Burn (2685); Skin Burning Sensation (4540)

Event Date 02/06/2021

Event Type  Injury  

Event Description

Ozone burnt my face and nose; i bought a clean zone s4 plus ozone cpap cleaner and used it daily for about a month.It took awhile to figure out why my skin where mask contacts started burning and turned hard and red.Then my nasal passage started giving me trouble.I stopped using the cpap cleaner and rinsed out all my parts, now the symptoms are getting better slowly.I am sure it was the ozone that caused the painful condition.Fda safety report id# (b)(4).

• Brand Name: CLEANZONE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): NATURES PILLOWS, INC. AND TOP DOG DIRECT, LLC
• MDR Report Key: 11343505
• MDR Text Key: 232624146
• Report Number: MW5099458
• Device Sequence Number: 1
• Product Code: LRJ
• 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: 02/13/2021

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: S4 PLUS
• Device Catalogue Number: CZ-1001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR