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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN2 - CPAP SANITIZING EQUIPMENT; DISINFECTANT, MEDICAL DEVICES
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SOCLEAN, INC. SOCLEAN2 - CPAP SANITIZING EQUIPMENT; DISINFECTANT, MEDICAL DEVICES Back to Search Results
Model Number SOCLEAN2
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994)
Event Date 01/01/2020
Event Type  Injury  
Event Description
In the fall of last year i purchased the soclean cpap cleaner.I used it to clean my cpap nose piece without problems for several months.But toward the beginning of the new year (2020).I began noticing that my nose was itching.Family members began commenting that my nose was red and wondered what was wrong.Suddenly the condition began worsening and the skin on my nose was actually painful.It became very hard to put my cpap on at night.I would wake up in the middle of the night with pain.So i changed the nosepiece to a brand new one.The thought occurred to me that the soclean cleaner might be involved.I stopped using it and within a week, the condition of my nose cleared up.I have not used the soclean since that time and the condition has not reoccurred.Fda safety report id # (b)(4).
 
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Brand Name
SOCLEAN2 - CPAP SANITIZING EQUIPMENT
Type of Device
DISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key10396586
MDR Text Key203131884
Report NumberMW5096044
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 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSOCLEAN2
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age70 YR
Patient Weight98
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