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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 Unexpected Therapeutic Results (1631)
Patient Problems Apnea (1720); Sleep Dysfunction (2517)
Event Date 10/20/2017
Event Type  Injury  
Event Description
Severe worsening of apnea; osa worsened considerably with use of this product, even when use was discontinued after a month. It took several years for sleep quality to return to what it used to be. Fda safety report id# (b)(4).
 
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Brand NameSOCLEAN
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key9786177
MDR Text Key182386542
Report NumberMW5093513
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 03/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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: 03/03/2020 Patient Sequence Number: 1
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