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

Device Problem Device Emits Odor (1425)

Patient Problems Irritation (1941); Pain (1994)

Event Date 04/27/2020

Event Type  Injury  

Event Description

Trouble breathing; i purchased a cleanzone cpap cleaner and i used it as instructed.I let my cpap air out and also kept it in the bag as instructed.The next day after using my cpap, i noticed that my throat hurt and my lungs hurt.I didn't use the cleanzone machine again and the pain has not gone away and my lungs continue to hurt.Because of the covid-19 situation, it isn't advised to see the doctor.I considered sending the machine back but, didn't want to take the chance of going to the po with the safer at home order in (b)(6).I have the operating instructions but, i think i threw the machine away because it was emitting a smell that hurt my throat.Fda safety report id # (b)(4).

• Brand Name: CLEANZONE CPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): NATURES PILLOWS, INC. AND TOP DOG DIRECT, LLC
• MDR Report Key: 10095976
• MDR Text Key: 192669617
• Report Number: MW5094706
• 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: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 64 YR
• Patient Weight: 134