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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN INC SOCLEAN 2 CPAP CLEANER DISINFECTANT, MEDICAL DEVICES

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SOCLEAN INC SOCLEAN 2 CPAP CLEANER DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2020
Event Type  malfunction  
Event Description
I was using soclean 2 for my cpap and started to notice charcoal like residue in my water chamber. I asked my cpap supplier about it and they asked if i used any cleaning device and told them i was using soclean 2. They instructed me to stop. I have a resmed machine and they told me that resmed will not honor warranty on any equipment that was purchased as of 2-20 and cleaned with soclean. I have had my machine for a couple of years so will be covered if need be but they advised me to stop using the soclean 2 which i did immediately. Fda safety report id #: (b)(4).
 
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Brand NameSOCLEAN 2 CPAP CLEANER
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN INC
MDR Report Key9971720
MDR Text Key188393026
Report NumberMW5094171
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 04/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2020
Is this an Adverse Event Report? No
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

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