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

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).

• Brand Name: CLEAN ZONE CPAP OZONE CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): TOP DOG, LLC /NATURES PILLOWS, INC. AND TOP DOG DIRECT, LLC
• MDR Report Key: 11148230
• MDR Text Key: 226076623
• Report Number: MW5098755
• Device Sequence Number: 1
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6310 CLEAN ZONE KIT
• Device Catalogue Number: ONLINE ONLY
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR