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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2; DISINFECTANT, MEDICAL DEVICES
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SOCLEAN, INC. SOCLEAN 2; DISINFECTANT, MEDICAL DEVICES Back to Search Results
Model Number SC1200
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Sensitivity of Teeth (2427)
Event Date 08/10/2020
Event Type  malfunction  
Event Description
I purchased a soclean device to clean my cpap at the recommendation of my cpap provider.After using the product, i started to have trouble breathing and consistent nasal issues.My wife has also experienced gum bleeding.I am furious that they recommended the device considering the lack of fda approval and potential issues.I was not made aware of the issues.I am also extremely concerned that this potentially puts my wife at greater risk of serious issues.She has heart failure due to issues with her lungs.Adding "activated oxygen" without telling us the risks could have exacerbated the her problem.They also have the fda logo on it, making it seem approved.After closer inspection, it says fda registered (b)(4).I understand that they are not supposed to be using the fda logo.Fda safety report id# (b)(4).
 
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Brand Name
SOCLEAN 2
Type of Device
DISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key10390619
MDR Text Key202370112
Report NumberMW5095997
Device Sequence Number1
Product Code LRJ
UDI-Device Identifier18729300086
UDI-Public18729300086
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? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberSC1200
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age4 MO
Patient Weight82
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