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U.S. Department of Health and Human Services

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

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TOP DOG, LLC /NATURES PILLOWS, INC. AND TOP DOG DIRECT, LLC CLEAN ZONE CPAP OZONE CLEANER DISINFECTANT, MEDICAL DEVICES Back to Search Results
Model Number 6310 CLEAN ZONE KIT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Dizziness (2194); Complaint, Ill-Defined (2331); Numbness (2415)
Event Date 01/06/2021
Event Type  Injury  
Event Description
Had breathing episode; after using clean zone from top dog, llc. My wife got sick from the smell and when i used my cpap after the instructions followed to the rule, i got very light headed, sick and could not breathe, my lips turned numb. I have returned the item today in the postal service to (b)(4), top dog, llc (b)(4). I wish the reviews showed all the issues and not the positive reviews they use for sales tactics. Fda safety report id # (b)(4).
 
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Brand NameCLEAN ZONE CPAP OZONE CLEANER
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
TOP DOG, LLC /NATURES PILLOWS, INC. AND TOP DOG DIRECT, LLC
MDR Report Key11148230
MDR Text Key226076623
Report NumberMW5098755
Device Sequence Number1
Product Code LRJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6310 CLEAN ZONE KIT
Device Catalogue NumberONLINE ONLY
Was Device Available for Evaluation? No
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: 01/11/2021 Patient Sequence Number: 1
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