MAUDE Adverse Event Report: SOCLEAN, INC. SO CLEAN CPAP CLEANER 3; DISINFECTANT, MEDICAL DEVICES

Patient Problems Dyspnea (1816); Headache (1880); Wheezing (4463)

Event Type  Injury  

Event Description

I was using the so clean 2 for 3 years and noticed i gradually was wheezing more with shortness of breath with something simple as walking.I also stayed having headaches and was hospitalized for a big episode and placed on medication.My family has a history of asthma but i did not symptoms.I just thought this was a sign of aging until i "upgraded " to the so clean 3.I immediate get my symptoms worsen so i switched to another brand without ozone.I mentioned this to my doctor who advised that she had heard some of her patient's complain about having similar issues.Since i stopped using the devices my headaches have improved and i no longer need the medication.I still have both units at my home and would like your help in finding out if there is a way to be compensated for my purchase.Reference report: mw5149430.

• Brand Name: SO CLEAN CPAP CLEANER 3
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 18372597
• MDR Text Key: 332493341
• Report Number: MW5149431
• 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: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American