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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
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Asthma (1726); Bronchitis (1752)
Event Date 02/10/2021
Event Type  Injury  
Event Description
My husband has a cpap and has used a soclean machine for a few years now. I have had chronic reactive airway disease, asthma, and chronic bronchitis during use. Dates aren't exact because the machine has been used daily for years. Fda safety report id # (b)(4).
 
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Brand NameSOCLEAN 2
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key12814339
MDR Text Key280872411
Report NumberMW5105310
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 11/10/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 11/12/2021 Patient Sequence Number: 1
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