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U.S. Department of Health and Human Services

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

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SOCLEAN, INC. SOCLEAN DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bronchitis (1752); Burning Sensation (2146)
Event Date 09/01/2020
Event Type  Injury  
Event Description
Severe bronchitis for months; i started using an ozone gas (soclean) to disinfect my cpap. After a month or so i developed bronchitis. After 4 months i am very ill. Can barely speak. Lungs feel like they are on fire. X-ray and blood work are ok. Going for ct scan next. I discontinued use of the ozone a couple weeks ago, but symptoms keep getting worse. Fda safety report id # (b)(4).
 
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Brand NameSOCLEAN
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key11087037
MDR Text Key224402639
Report NumberMW5098549
Device Sequence Number1
Product Code LRJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
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: 12/28/2020 Patient Sequence Number: 1
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