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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2 CPAP SANITIZER; DISINFECTANT, MEDICAL DEVICES
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SOCLEAN, INC. SOCLEAN 2 CPAP SANITIZER; DISINFECTANT, MEDICAL DEVICES Back to Search Results
Model Number SC1200
Device Problem Product Quality Problem (1506)
Patient Problems Asthma (1726); Dyspnea (1816)
Event Date 04/05/2020
Event Type  Injury  
Event Description
Chronic asthma; i received my soclean 2 cpap sanitizer in mid (b)(6) 2020, directly from the manufacturer.I used it daily to clean my cpap machine.After a couple of weeks, i developed chronic wheezing and shortness of breath.I own an inhaler for rare bouts of wheezing, but i'm never bothered by asthma for more than a day or two.This time, however, i was using my inhaler several times a day for over two weeks - a condition i had never experienced before.That's when i stumbled across an article that warned that such cleaning devices that use ozone as a disinfectant could cause lung issues.I immediately stopped using the soclean and my asthma cleared up in about a week and has not returned since.It is now mid (b)(6) with tons of pollen in the air and i feel fine.Should add that i've been in self-isolation since the time i got my soclean, so my wheezing was not due to exposure to covid-19.Fda safety report id# (b)(4).
 
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Brand Name
SOCLEAN 2 CPAP SANITIZER
Type of Device
DISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key10162400
MDR Text Key195552477
Report NumberMW5095021
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 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSC1200
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 Age187 YR
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