MAUDE Adverse Event Report: SO CLEAN, INC. SO CLEAN 2; DISINFECTANT, MEDICAL DEVICES

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

Patient Problems Dyspnea (1816); Pneumonia (2011)

Event Date 04/09/2021

Event Type  malfunction  

Event Description

Bilateral/multi-focal pneumo; i was having extreme problems breathing.Current user of cpap machine.Was suggested to use a so clean machine by cnp.In (b)(6) 2021 i started having issues.I already had asthma.The breathing issues kept getting worse.Thought was bronchitis and was treated with bronchitis.Wouldn't go away.So in (b)(6) i went to emergency room.They did ct scan of my lungs.They diagnosed me with covid pneumonia but all my covid tests had been negative.My cough didn't seem to get better.It seemed to have a smell to the cough.It took me a few days to figure it out.My phlegm coming out smells like the ozone filter in the so clean machine.Happened for weeks.Still happens but a little less now.My sinuses also have been infected for weeks now.Been on 3 antibiotics since first diagnosed.I asked for the antibodies test 5 weeks later since my cough smelled like the ozone smell.It was negative.I never had covid, so it couldn't have been covid pneumonia.The only other thing that could've caused that was the cpap and so clean.I reported to my sleep medicine dr and she told me that the machine is capable of damage to lungs and i need to report.Fda safety report id # (b)(4).

• Brand Name: SO CLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SO CLEAN, INC.
• MDR Report Key: 11912399
• MDR Text Key: 253870840
• Report Number: MW5101619
• 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: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 115