MAUDE Adverse Event Report: SOCLEAN INC. SOCLEAN2; DISINFECTANT, MEDICAL DEVICES

Model Number SOCLEAN2

Device Problems Device Emits Odor (1425); Defective Device (2588)

Patient Problems Headache (1880); Cough (4457); Unspecified Respiratory Problem (4464)

Event Type  Injury  

Event Description

We purchased a soclean2 cpap cleaner on (b)(6) 2021.We were informed by (b)(6) health that this was a safe and best way to clean the cpap machine.We started noticing issues about 1 month in.However, we called (b)(6) health a few times and they said it was normal and that we just need to get used to the smell.It is just "clean ozone." (my husband started coughing and having breathing difficulties and random headaches.) we also noticed that we can not be in the same room within at least 1 1/2 hours after the device has stopped.(even though the rep told us it was safe to be in the room while it is running.)long story short, 9 months in and we stopped using the soclean 2 to clean the cpap machine.We noticed that my husband's symptoms have reduced dramatically.Then we came upon the fda warnings by chance.These items should be pulled off the market.I am hoping that there is no longer-term ill effect that my husband will sustain from using the soclean2 for 9 months.We want to file a complaint regarding false advertisement and soclean2 selling products that are harmful.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN INC.
• MDR Report Key: 13734096
• MDR Text Key: 287191367
• Report Number: MW5108028
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 00187293000860
• UDI-Public: 187293000860
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOCLEAN2
• Device Catalogue Number: SOCLEAN
• Device Lot Number: SC1200
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian