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U.S. Department of Health and Human Services

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

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NATURES PILLOWS, INC., AND TOP DOG DIRECT, LLC CLEAR ZONE DISINFECTANT, MEDICAL DEVICES Back to Search Results
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).
 
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Brand NameCLEAR ZONE
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
NATURES PILLOWS, INC., AND TOP DOG DIRECT, LLC
MDR Report Key10442813
MDR Text Key204231447
Report NumberMW5096204
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received08/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS4 PLUS STYLE #CZ-1001
Device Catalogue Number? MADE IN CHINA
Device Lot NumberUN 3481
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/21/2020 Patient Sequence Number: 1
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