MAUDE Adverse Event Report: SOCLEAN, INC. SO CLEAN BI-PAP CLEANING DEVICE; DISINFECTANT, MEDICAL DEVICES

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

Patient Problem Headache (1880)

Event Date 03/01/2020

Event Type  Injury  

Event Description

I noticed that i had an increased in migraine headaches and cough since quarantine began in (b)(6).It wasn't until i read about the fda information on the so clean product and ozone release that i realized it could related.Since lock down, i have been sitting in my bedroom watching the morning news daily as the machine cleans my bi-pap tubing for 8 minutes.I did smell the ozone but didn't connect it to my symptoms.Prior to that, i was working even though i am retired.I have a history of migraines and asthma.I was actually looking up a new so clean product to clean phones and wallets when i came across the fda article published in february 2020.I stopped using the machine that day and my symptoms have improved dramatically already.I plan to contact the company to ask for reimbursement for the 3 filter kits i bought last (b)(6) but have not used yet.Fda safety report id # (b)(4).

• Brand Name: SO CLEAN BI-PAP CLEANING DEVICE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 10482440
• MDR Text Key: 205500567
• Report Number: MW5096374
• 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: 08/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 59