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

Health Effect - Clinical Codes	Dyspnea (1816); Vertigo (2134); Dizziness (2194); Dysphasia (2195)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Constant lightheadedness and vertigo, as well as shortness of breath and ability to talk coherently.Many specialists have evaluated me, but everything appears fine or normal for my age (65).The suspected cause soclean 2 leaking ozone into the bedroom and remaining in the tube.I purchased a soclean 3 and installed it and used it 2 times and pulled it and returned it after reading about the ozone issues.I was told there is no test to determine if i have ozone in my body.I have seen many doctors and no one can tell me why i'm always dizzy.After researching soclean, i determined that the door and hose entry are not tight, therefore leaking ozone into the bedroom.My wife is having asthma attacks, which she never had before.I removed the soclean 2 weeks ago.My wife is noticing a change.I haven't.We purchased a $600 nuwave airpurifier and it has been running for at least 2 weeks, and still no change.I'm willing to see any specialist or take any medical test to determine what is wrong with me.Reference report mw5148541.

• Brand Name: SOCLEAN 3
• Common Device Name: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN INC.
• MDR Report Key: 18237090
• Report Number: MW5148542
• Device Sequence Number: 7642604
• Product Code: LRJ
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 11/22/2023

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
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPRIN.; ATORVASTATIN 40MG.; B12.; LINSOPRIL 40MG.; METFORMIN.; NEXIUM 40MG.; TAMSULOSIN.; XYZAL.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White