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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. CPAP OZONE CLEANER DISINFECTANT, MEDICAL DEVICES

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SOCLEAN, INC. CPAP OZONE CLEANER DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Asthma (1726); Bronchitis (1752); No Code Available (3191)
Event Date 02/20/2019
Event Type  Injury  
Event Description
Approximately six years ago, i was diagnosed with sleep apnea and began using a cpap machine. I think it was about 4 years ago, i purchased a so clean machine to keep my equipment clean. Since the machine was hsa and fsa approved, i felt more confident that it would do what it was designed to do and that it was a safe method of cleaning. Around (b)(6) of 2018, (i can go back to my drs and get exact dates if needed) i started taking sublingual drops for allergies. In roughly (b)(6) of 2019, i became very ill with bronchitis and while not diagnosed my chest closed to the point that i felt i may have had pneumonia. I called my allergist and she told me to stop taking the sublingual drops until i was better. Not using the cpap wasn't considered because my sleep dr. Had previously told me that it could only help my breathing and to use it when i was sick. Note: in all the years that i have had the cpap, i have only missed using it a handful of nights, my diagnosis was severe sleep apnea so i wear my gear religiously. Once i finally got better, i was left with a debilitating cough. The cough would come on suddenly just from breathing and sometimes when i took a breath in, i would have to cough it out. While this improved some with time, it never went away and asthma attacks started coming more frequently. I went to see my ent to see what he thought about the possibility of the drops being the cause. He did not believe that the sublingual drops would cause the chronic cough i had developed. I coughed my way through most of 2019 and during that time most of the "sartan" drugs were being recalled. I took losartan for bp. I asked my dr. If he could just change my medication and was given lisinopril. I had a bout of afib several years ago, and i started feeling dizzy and felt like i couldn't catch my breath; so i made an appointment with my heart dr. In the course of that visit when i told him about my breathing difficulties, dizziness and chronic cough, he asked me about the lisinopril. He said it was known to cause a cough. I let him know that the cough had started before the lisinopril but on his recommendation went back to losartan for bp and started on metoprolol. Still, i had coughing fits that made it difficult to go out in public. My sleep dr. Had retired and i had just been having my general practitioner take care of my equipment prescriptions for hoses and head gear. During the (b)(6) of 2020, my cpap equipment was leaving me very dry even though the humidifier was on. I would wake up coughing and have a very raw, dry mouth. I decided that i needed to buy a new cpap machine. Once the problem with the cpap equipment happened, i began to look at the so clean and my gear as well. I noticed that my head gear was yellowing and the nose pillow was as well (i do not smoke) even though they were not very old. I felt inside of the nose pillow and it was gooey like the rubber itself was breaking down. I immediately took all my gear and washed it in (b)(6) and vinegar and all of the yellowing washed off except for the headgear. I had also noticed that there was a disturbance in my throat that seemed to be right at the spot where the air from the cpap hit. Since i had not been to the sleep dr. In several years and since i was now getting a new machine, i sat up an appointment with my sleep specialist. That appointment was in (b)(6) 2020. During that appointment, i described all of the things that had happened and that i had now been dealing with the chronic cough for about 1 1/2 years. She provided me with the fda paper from (b)(6) 2020 about so clean complaints. I quit using the so clean about two weeks ago after going to that dr. I do not know if this can be reversed but i do believe that the so clean has taken away my breath and is the cause of this chronic cough. I do not know if there is a way to test and determine if ozone is in my lungs or if i can ever get over this. Please take away their fsa/hsa approval. Fda safety report id# (b)(4).
 
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Brand NameCPAP OZONE CLEANER
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key10396017
MDR Text Key202735462
Report NumberMW5096012
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 08/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/11/2020 Patient Sequence Number: 1
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