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U.S. Department of Health and Human Services

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

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SOCLEAN, INC. SO CLEAN DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problems Device Emits Odor (1425); Patient-Device Incompatibility (2682)
Patient Problems Asthma (1726); Dyspnea (1816); Vomiting (2144)
Event Date 09/18/2021
Event Type  Injury  
Event Description
My husband uses soclean to clean his cpap. There were times that i would have asthma attack or difficulty to breath whenever he would face me with his cpap in use - the air from his cpap would hit me on my face. And the smell from his cpap after cleaning with soclean would throw me up. Fda safety report id # (b)(4).
 
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Brand NameSO CLEAN
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key12532444
MDR Text Key273591471
Report NumberMW5104196
Device Sequence Number1
Product Code LRJ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
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: 09/24/2021 Patient Sequence Number: 1
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