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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Cough (4457)

Event Date 01/01/2021

Event Type  Injury  

Event Description

I have a chronic cough for approximately 6 1/2 months now.In early (b)(6) i was on cough medicine for 14 days trying to get rid of it didn't work, (b)(6) i went to the doctor he put me on two different inhalers proventiall and cortisone for six weeks didn't help.About two months ago he put me on prednisone for 11 days and new inhaler didn't help either.I had an x-ray and my lungs are fine, they said, doctor doesn't know why i keep coughing.I still have the cough i used the cpap with the so clean device and truly believe this is my problem ,i had to start on constant use of the inhalers i do have asthma but i have not used inhalers for at least five or seven years now all of a sudden it's a daily thing.They help me slightly but i'm still coughing that hard it makes my head hurt and it makes other peoples ears hurt.It ruined my resimed cpap that i had for 4 years and then i got a new dream station machine and it broke after 11 months now i'm on the third dream station machine and it started to act up so i am in the process of getting another cpap machine.I just found out today (b)(6) 2021 that this is causing problems with peoples lungs and the cpap machines ,because of the ozone it uses, i truly believe now that this is what my problem has come from and i don't know how i'll get rid of this chronic cough.None of the companies reported the problem to me i found out on (b)(6).There are times when my throat feels like it is closing and when i breathe in air from the air conditioner or sometimes just air it seems to do something in my throat that will bring on this cough.Fda safety report id# (b)(4).

• Brand Name: SO CLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12149432
• MDR Text Key: 261238035
• Report Number: MW5102436
• Device Sequence Number: 2
• 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: 07/07/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 100