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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SO CLEAN INC. SO CLEAN CPAP CLEANER; DISINFECTANT, MEDICAL DEVICES
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SO CLEAN INC. SO CLEAN CPAP CLEANER; DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Hemoptysis (1887); Dizziness (2194)
Event Date 04/01/2021
Event Type  Injury  
Event Description
Shortness of breath, dizziness; my dad feels like something is in his throat, he went to ent, they couldn't see anything and referred him to digestive health.An appointment was scheduled for 6 weeks later, in the meantime he started having shortness of breath and went to an urgent care clinic.The np thought heart issues so scheduled him with cardiologist.They did several tests, couldn't find a problem.They did a ct of lung and found a spot.Sent to pulmonary dr and now he is scheduled for biopsy.He discussed his breathing issues and pulmonologist said spot shouldn't cause this.He continues to have this problem, also hoarseness and coughing up bloody mucus.He has used the so clean cpap cleaner for about two years, when i researched i read about ozone concerns from use.We are not sure what to do at this point still trying to figure out what is causing his problems.Any help would be appreciated.Fda safety report id # (b)(4).
 
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Brand Name
SO CLEAN CPAP CLEANER
Type of Device
DISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SO CLEAN INC.
MDR Report Key12353963
MDR Text Key267959153
Report NumberMW5103403
Device Sequence Number1
Product Code LRJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 08/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2021
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
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age79 YR
Patient Weight113
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