MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 3; DISINFECTANT, MEDICAL DEVICES

Model Number	MODEL 3
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
Date of Event	02/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
For 14 years, i have been on continuous positive airway pressure therapy, and use it every night, without fail.I've used redmed s9 continuous positive airway pressure and now have an s10.I started out using a soclean 2, and recently upgraded to a soclean 3, with the water chamber adapter, 4 years ago.Shortly after using the soclean 3, about 3 years ago, the area around my nose started chaffing and stinging.Not thinking this was soclean related, i spoke with redmed and my supplier of equipment and they explained it might be from too much moisture in the continuous positive airway pressure, so i turned that setting down.The chaffing and stinging continued.Next i thought it was because my mirage fx nose mask was not cleaned enough, so i cleaned and changed it more frequently.Still did not help.Finally i decided to not put the mask in the soclean 3.I removed the mask and just put the hose and let the soclean 3 bubble through the water chamber and clean the hose.Fast forward to today.I'm noticing that, despite the resmed showing me 100% usage, no leaks, i'm waking up tired, with a headache, and don't understand why.I was also diagnosed with an idiopathic pulmonary issue "tree in bud" formations, despite i was tested for and have no allergies (both prick test and blood test).I reached out to soclean thinking it was water reservoir adaptor leaking.I wanted to buy a replacement.They explained they don't sell those anymore.Instead, they sent me an adaptor which bypasses the continuous positive airway pressure altogether, and only cleans the hose.Much to my surprise, i'm feeling better now, although not back to 100% however i don't know why i am even using the soclean 3 now, as it only cleans the hose, not the mask (cause the mask hurts to wear after ozone).I believe that even using the adaptor hose attachment to clean just the hose is still leaving me a little bit out of energy.I plan to completely discontinue the use of soclean.This product should be banned from the market.I clean my continuous positive airway pressure equipment in 185 degree water every week and i think this works well.Soclean updated their documentation to say "not to use any plastic products in the device" well, that basically excludes everything about a continuous positive airway pressure, the tubing, the mask, and the headgear, everything is made of plastic in one form or another.Every time i contacted the manufacturer about issues, they provide alternatives, instead of logging as an adverse reaction.

• Brand Name: SOCLEAN 3
• Common Device Name: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 21378502
• Report Number: MW5166148
• Device Sequence Number: 8517169
• Product Code: LRJ
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 02/08/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: MODEL 3
• Device Catalogue Number: XTSC1400IDR
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATORVASTATIN.; CLARITIN.; FISH OIL.; FLONASE.; HYDROXYUREA.; MAGNESIUM.; MULTI VITAMIN.; OMEPRAZOLE.; RESMED S10 CPAP.; VITAMIN C.; VITAMIN D.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White