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

Model Number S4 PLUS

Device Problem Device Emits Odor (1425)

Patient Problems Dyspnea (1816); Dizziness (2194); Sleep Dysfunction (2517)

Event Date 05/18/2020

Event Type  Injury  

Event Description

I have been using the "clean zone" to disinfect my cpap hose, mask, and water container for almost a month.((b)(6) 2020) i have noticed a strong odor after cleaning with the clean zone machine.I even turn the cpap on to possibly clear the odor for about 30 min after i clean.Last night, (b)(6) 2020, i got up, started walking.(i had been having difficulty sleeping) i experienced dizziness and shortness of breath for about 3-4 minutes.I carefully walked back to bed and rested for about 5 min.The dizziness and sob stopped.I put on the cpap mask.After about 3 minutes of turning on the cpap, i opened my eyes and saw the room spinning as i had when i was walking.The type of dizziness was unusual for me.I also have been having restless leg and cramping of the legs for a couple of weeks, so i have connected this side effect to the ozone cleaning method, but i am not sure of that.I have called my pulmonologist and have not heard from him yet.Fda safety report id# (b)(4).

• Brand Name: CLEAN ZONE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): NATURES PILLOWS, INC., AND TOP DOG DIRECT LLC
• MDR Report Key: 10082293
• MDR Text Key: 191980846
• Report Number: MW5094634
• 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: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• 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-1000
• 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): Disability
• Patient Age: 71 YR
• Patient Weight: 113