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

Device Problem Nonstandard Device (1420)

Patient Problems Dyspnea (1816); Fever (1858); Cough (4457)

Event Date 06/25/2021

Event Type  Injury  

Event Description

I use phillips respironic dream station cpap machine with full face mask.A few months ago i tried clean zone cpap cleaner.After trying it, i could not breath using the cpap machine (because of the very intense odor) and let it run outside for three days to remove the odor.Now i use it nightly again.Approx (b)(6) 2021 i came down with a hard, deep cough, congestion in chest and a fever.After several days of not getting better i went to my pcp and was prescribed steroids and antibiotic.I stayed home for 2 weeks and became well again, except for large amounts of phlegm every morning, and a "frog in my throat" that is pretty much with me all the time now.Today i found that there is a recall on certain phillips cpap machines and am thinking this mystery lung event could be related.I saw my allergist this week and he visually checked my throat and found nothing unordinary.After researching the ozone cpap cleaner, i researched the fda's website and found the dangers.I then contacted my health insurance company and made them aware of the dangers.They pulled the product and do not offer ozone cleaners any more.((b)(6)).Fda safety report id # (b)(4).

• Brand Name: CLEAN ZONE CPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): NATURES PILLOWS, INC. AND TOP DOG DIRECT, LLC
• MDR Report Key: 12210751
• MDR Text Key: 263134838
• Report Number: MW5102695
• Device Sequence Number: 2
• 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: 07/15/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 61 YR
• Patient Weight: 107