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U.S. Department of Health and Human Services

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

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SOCLEAN, INC. SOCLEAN CAPAP CLEANER DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Bronchitis (1752)
Event Date 06/01/2021
Event Type  Injury  
Event Description
Been having on and off issues with acute bronchitis that may be associated with use of cpap soclean unit. Been having the issue on and off since purchasing the machine and most recently having it and no antibiotics or other meds have helped. In looking for possible reasons, i began to wonder about the soclean equipment. Continuing bronchial irritation. Fda safety report id# (b)(4).
 
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Brand NameSOCLEAN CAPAP CLEANER
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key12050295
MDR Text Key258176079
Report NumberMW5102048
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 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
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: 06/22/2021 Patient Sequence Number: 1
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