MAUDE Adverse Event Report: SOCLEAN INC. SOCLEAN OZONE CPAP CLEANING DEVICE; DISINFECTANT, MEDICAL DEVICES

Model Number SOCLEAN 2 REF SC1200

Device Problem Nonstandard Device (1420)

Patient Problems Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 10/01/2021

Event Type  Injury  

Event Description

I bought a soclean machine last year to clean my cpap parts.I used it as directed.I could smell ozone in my bedroom and my wife could also.She has had a cough for months but it is probably from a sinus problem.Even though i purge the cpap system for about 5 minutes on the mask fit setting, i still smell ozone.I have a cough that varies from time to time from slight to very severe coughing where i almost lose my breath.I went to my sleep center doctor yesterday, (b)(6) 2022, and my doctor told me to never use the soclean ever.He said that washing the cpap parts was the only way to clean them.He said that soclean was in part responsible for the philips respironics recall.I don't know why the soclean is not taken off the market.I have since looked up information and found that the fda doesn't recommend ozone producing devices at all and that soclean and other devices are not approved by the fda and it's not approved for marketing.It is directly because of all the ads for soclean that i bought the device in the first place.My naturopathic doctor has given me instructions on a nebulizer to relieve the irritation in my lungs.I don't have a diagnosis yet on the exact cause of the coughing but i didn't have this problem before even with a past history of seasonal allergies to hay, grass, poplar trees, cats and dogs.I never had this severe of a cough in past years before or after taking allergy shots years ago.I am going to return to my doctor for further testing on this but i wanted to initiate a report to the fda as soon as possible.I will try to get any tests that could determine the cause of the coughing.I have not had any tests directly to determine the cause of the coughing or to determine the condition of my lungs.I had the moderna covid19 vaccines in (b)(6) 2021 just for information.I take over the counter cough suppressants in daytime and nighttime formulas.I sleep fairly well using my cpap machine.I have no other particular health problems.I am (b)(6).I had a physical recently which included a ct scan of my heart that said stated my chronological age as (b)(6) and heart health relative range is less than 35-years-old with a chance of a cardiac event being 0.1% chance.I am active and don't smoke or drink.I live in a rural environment and work in a small population area of (b)(6).I'm not including a photo of my soclean machine as it looks the same as the ads.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN OZONE CPAP CLEANING DEVICE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN INC.
• MDR Report Key: 14416539
• MDR Text Key: 291958098
• Report Number: MW5109742
• 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: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOCLEAN 2 REF SC1200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2022
• Patient Sequence Number: 1
• Treatment: AIRSENSE 10; B12 COMPLEX; CPAP MACHINE; D3 4000 IU; FOCUS FACTOR MULTI VITAMIN; KIRKLAND COQ10 300MG; PREGNENOLONE 50 MG; PURE B6 COMPLEX; THYROID 1 GR DAILY; VIT C 1000 MG; ZINC 50MG
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White