MAUDE Adverse Event Report: SOCLEAN INC. SOCLEAN 2 GO; SOCLEAN INC

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Dyspnea (1816)

Event Date 01/02/2020

Event Type  Injury  

Event Description

I was using the soclean 2 go (original small travel unit) to clean cpap for a year or two.Initially i did not have any issues.I developed copd at some point after the initial year or so.I suddenly had acute incidents of not being able to catch my breathe.Even my pulmonologist was puzzled as to the cause.My copd wasn't at a level to cause this.I did not use inhalers.There was no research to be found on ozone and copd.I realized on my own that it might be the soclean device so i stopped.While i do feel the effects of copd, i have not had the acute incidents of not being able to catch my breath like i experienced when using the soclean.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN 2 GO
• Type of Device: SOCLEAN INC
• Manufacturer (Section D): SOCLEAN INC.
• MDR Report Key: 11116762
• MDR Text Key: 225328397
• Report Number: MW5098659
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): Y
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 65 YR
• Patient Weight: 84