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U.S. Department of Health and Human Services

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

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SOCLEAN, INC. DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Headache (1880); Burning Sensation (2146); Complaint, Ill-Defined (2331)
Event Date 04/01/2020
Event Type  Injury  
Event Description
A patient called to report the adverse effects he experienced after using a cpap cleaning product. After seeing a commercial on tv he started using this product. He said after using it for quite sometime one day he woke up and he could not breath, his nasals were feeling like they were on fire, headache, sore throat, a lot of mucus and was having lung issues. He thought he was having covid-19 and he took the test and it came back negative. He said he found out that this cleaner is not approved by fda for this purpose, they are marketing it illegally. He said he was told the ozone gas is way above that a human should be around. Even though he stopped using it, he is still having issues so he is scheduled to see an ent specialist.
 
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Brand NameDISINFECTANT, MEDICAL DEVICES
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key10320020
MDR Text Key200459510
Report NumberMW5095704
Device Sequence Number1
Product Code LRJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/23/2020 Patient Sequence Number: 1
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