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

Model Number S4 PLUS STYLE #CZ-1001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Eye Injury (1845); Headache (1880); Pain (1994); Visual Disturbances (2140); Discomfort (2330); Nasal Obstruction (2466); Missing Value Reason (3192)

Event Date 08/01/2020

Event Type  Injury  

Event Description

I bought a cpap cleaning device called clean zone.I started to use it on (b)(6) 2020.After about 2 weeks i started to notice a heavy cough, difficulty breathing, nasal blockage, pain around the left eye and pain in my left temple area.The most serious problem was the floaters in my left eye.I went to my eye doctor (b)(6) 2020, at the (b)(6).They did a battery of test, ie, dilation, eye reading chart, magnification of the retina, ultraviolet checking, or all the known test to see behind the eye and its blood vessels, and came to the conclusion of having an eye stroke.The doc's also did blood tests on this matter, (b)(6) 2020.I also have every 6 months regular check ups, blood tests, the works.I also have annual heart ct scans, (last done (b)(6) 2020), ct scans on the lungs, ((b)(6) 2020), and all tests are coming back with positive results.I do smoke, but at about 4 to 5 cigarettes a day, have cut down on salt intake etc.Before i used this clean zone device on my cpap machine i did not have an eye problem at all.I also notice that after i followed the recommended cleaning procedures of this machine i smell and tasted an offal odor and taste.As of today i still have the eye problem, a discomfort, bad taste coming from my lungs, eye aches and slight to moderate headache on the left side like a migraine.Fda safety report id# (b)(4).

• Brand Name: CLEAR ZONE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): NATURES PILLOWS, INC., AND TOP DOG DIRECT, LLC
• MDR Report Key: 10442813
• MDR Text Key: 204231447
• Report Number: MW5096204
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: S4 PLUS STYLE #CZ-1001
• Device Catalogue Number: ? MADE IN CHINA
• Device Lot Number: UN 3481
• 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): Other; Required Intervention; Disability
• Patient Age: 62 YR
• Patient Weight: 115