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

Device Problem Product Quality Problem (1506)

Patient Problems Dyspnea (1816); Inflammation (1932); Cough (4457); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/23/2019

Event Type  Injury  

Event Description

I got a new cpap machine and at this time i decided to get the so clean machine to keep it sanitized.It was being advertised as being very effective and replaced the rigorous cleaning needed.After 5 months of use i started having shortness of breath, chronic cough, dry throat, lung inflammation.I then was sent to a pulmonologist had many test.I did have mild asthma at that time the testing showed.Started on meds for it.Also had endoscopy.Echo cardio gram.After months of treatment dr have still not found the cause of my chronic cough.I ran across a recall on my cpap and that led me to an issue and complaints by many user of the so clean.Many of their symptoms were same as mine fda safety report id# (b)(4).

• Brand Name: SO CLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12050235
• MDR Text Key: 258699204
• Report Number: MW5102046
• 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: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• 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): Disability
• Patient Age: 67 YR
• Patient Weight: 110