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

Model Number SC1200

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

Patient Problems Chest Pain (1776); Dyspnea (1816); Cough (4457)

Event Date 06/01/2021

Event Type  Injury  

Event Description

Lung irritation, cough; purchased a "so clean" cpap sanitizing device in 2020 and have been using it 2-3 times per week (not daily) as i had read reports that ozone can damage cpap internal components (e.G., rubber gaskets, etc.).Several months after first use, i noticed a black residue appeared in my water reservoir, directly under the black rubber hose from the so clean device.Over the past several months, the black residue has continued to accumulate in the reservoir and i have been removing it the best i can.It has settled into the fine seams along the reservoir's sides.I am cleaning the device components using soap and water but still using the so clean every 2-3 days.In the past couple of weeks, i have noticed a distinct pain in my lungs and coughing at night after i start using my cpap, requiring me to remove the mask and catch my breath.I believe the so clean's ozone may be causing damage to its black colored rubber hose components to the point that the hose material is ending up in the reservoir and being inhaled by me.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN INC.
• MDR Report Key: 12032322
• MDR Text Key: 257546863
• Report Number: MW5101981
• Device Sequence Number: 1
• 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: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SC1200
• 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: 50 YR
• Patient Weight: 100