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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
Model Number SC1200
Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)
Patient Problems Chest Pain (1776); Dyspnea (1816); Cough (4457)
Event Date 06/01/2021
Event Type  Injury  
Event Description
Lung irritation, cough; purchased a "so clean" cpap sanitizing device in 2020 and have been using it 2-3 times per week (not daily) as i had read reports that ozone can damage cpap internal components (e. G. , rubber gaskets, etc. ). Several months after first use, i noticed a black residue appeared in my water reservoir, directly under the black rubber hose from the so clean device. Over the past several months, the black residue has continued to accumulate in the reservoir and i have been removing it the best i can. It has settled into the fine seams along the reservoir's sides. I am cleaning the device components using soap and water but still using the so clean every 2-3 days. In the past couple of weeks, i have noticed a distinct pain in my lungs and coughing at night after i start using my cpap, requiring me to remove the mask and catch my breath. I believe the so clean's ozone may be causing damage to its black colored rubber hose components to the point that the hose material is ending up in the reservoir and being inhaled by me. Fda safety report id # (b)(4).
 
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Brand NameSOCLEAN
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN INC.
MDR Report Key12032322
MDR Text Key257546863
Report NumberMW5101981
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 06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSC1200
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: 06/17/2021 Patient Sequence Number: 1
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