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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN INC. SOCLEAN 2; DISINFECTANT, MEDICAL DEVICES
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SOCLEAN INC. SOCLEAN 2; DISINFECTANT, MEDICAL DEVICES Back to Search Results
Catalog Number SC1200-SB
Device Problems Device Emits Odor (1425); Gas/Air Leak (2946)
Patient Problems Autoimmune Reaction (1733); Fatigue (1849); Headache (1880); Inflammation (1932); Nausea (1970); Blurred Vision (2137); Dizziness (2194); Sore Throat (2396)
Event Date 06/01/2020
Event Type  Injury  
Event Description
My partner has been using the soclean product to clean his cpac machine since about (b)(6) 2020.I have literally been extremely sick for almost a year.Dizziness, nausea, sore throat, fatigue, blurry vision, eye strain, extreme headache, lungs inflamed, excess phlegm, autoimmune problems with my skin.I thought it was covid.My doctor couldn't find an answer.I was put on steroids, which aggravated the situation.I just finally put it all together.I have been smelling ozone but i didn't know it was dangerous.Basically, i have been breathing poison all this time.In 2 days without the machine on and airing out my house i am feeling much better.Most symptoms have gone away.I have missed a lot of work, vacations and other activities because of this.This has been an exhausting and horrible process.Please share the info about how dangerous this is.Fda safety report id # (b)(4).
 
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Brand Name
SOCLEAN 2
Type of Device
DISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN INC.
MDR Report Key11377930
MDR Text Key233782054
Report NumberMW5099616
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 02/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberSC1200-SB
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Age67 YR
Patient Weight70
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