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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN MACHINE; DISINFECTANT, MEDICAL DEVICES
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SOCLEAN, INC. SOCLEAN MACHINE; DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problems Device-Device Incompatibility (2919); Patient Device Interaction Problem (4001)
Patient Problem Cough (4457)
Event Date 07/07/2021
Event Type  Injury  
Event Description
I have been using a philips c-pap dream machine for several years.In june, at my doctor's suggestion, i bought a so clean at machine.A month later i woke up with a bad cough that is almost constant and won't go away.Sometimes throughout the day, i cough so hard i almost vomit.I was perfectly healthy until this cough started.It's been going on for three and a half months now.I had chest xrays, ct scans, a bronchoscopy, blood tests, and the doctors can't figure out what is causing this cough.I have been on numerous antibiotics, inhalers, and steroids, none of which help.I never smoked and i was perfectly healthy before this, never even catching a cold from my schoolage grand kids who live with us.Nor has anyone i've been around caught this cough from me.Sudden debilitating cough.I have more tests than i can list all came back negative for anything specific.All the doctors told me was there is a white area in my lower left lung.The biopsy hasn't shown anything specific.Fda safety report id# (b)(4).
 
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Brand Name
SOCLEAN MACHINE
Type of Device
DISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key12703903
MDR Text Key278790442
Report NumberMW5104965
Device Sequence Number2
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 10/23/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/26/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age67 YR
Patient Weight75
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