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

Model Number SOCLEAN 2

Device Problem Insufficient Information (3190)

Patient Problems Headache (1880); Discomfort (2330)

Event Date 02/12/2023

Event Type  Injury  

Event Description

Ongoing problems when using a soclean cpap cleaning machine.I've had headaches since using the machine several years ago, but i didn't realize that the cause was the soclean machine.On (b)(6) 2023, i had sores in my mouth in 2 places and i looked online to see if the ozone from the soclean machine could be the source.Then i read that headaches are another possible problem caused by machines that use ozone to clean cpap machines.I stopped using the soclean machine and began cleaning the cpap with soap and water and the mouth sores cleared up.However, the biggest benefit of using soap and water instead of the soclean machine is that headaches have stopped.It was like turning off a switch, the improvement was so dramatic.

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 16502633
• MDR Text Key: 310969030
• Report Number: MW5115520
• 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: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOCLEAN 2
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALLOPURINOL; ASPIRIN; CPAP MACHINE; FENOBIBRATE; FOLIC ACID; ONE A DAY MEN'S VITAMIN
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 116 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White