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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN INC SOCLEAN; DISINFECTANT, MEDICAL DEVICES

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SOCLEAN INC SOCLEAN; DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/05/2021
Event Type  Injury  
Event Description
Er visit, poor chest ct; i have used a soclean device since purchasing a cpap two years ago.During an er visit for excruciating rib pain, i had a ct of my chest.It showed several unusual changes in my lungs that could indicate chronic bronchitis or sarcoidosis.I personally believe the culprit is the soclean device and depending on it to clean/sanitize my equipment for the past two years.I have stopped using the device and am hand-washing the tubing and mask.My breathing is improving some how.It has been 19 days since i stopped using it.Fda safety report id # (b)(4).
 
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Brand Name
SOCLEAN
Type of Device
DISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN INC
MDR Report Key11392073
MDR Text Key234269060
Report NumberMW5099680
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 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/26/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age69 YR
Patient Weight87
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