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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN FAMILY OF PRODUCTS; DISINFECTANT, MEDICAL DEVICES
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SOCLEAN, INC. SOCLEAN FAMILY OF PRODUCTS; DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problem Output Problem (3005)
Patient Problems Headache (1880); Inflammation (1932); Swelling/ Edema (4577)
Event Date 08/07/2019
Event Type  malfunction  
Event Description
Inflammation headaches; i have a phillips respironic first generation dreamstation bipap since 2018 and was never previously warned about the risks of using a so clean device to clean the bipap.I am concerned that neither the respiratory therapist, nor doctor that authorized the need for bipap therapy, gave a thorough viewpoint of risk using the cleaning method.I used the so clean in good faith that i was doing all that i could to keep me and loved ones safe from catching covid that lived in my home.I did use the cleaning method no more than 5-6 times a year.I am concerned now i have noticed some swelling and inflammation in and around chest area and unsure why.I am concerned that phillips respironic has noted that possibly the warranty may be nullified if customers have used the ozone cleaning method that they were never fully aware of the risks to begin with.Fda safety report id# (b)(4).
 
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Brand Name
SOCLEAN FAMILY OF PRODUCTS
Type of Device
DISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key12287440
MDR Text Key265642855
Report NumberMW5103041
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 08/03/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age45 YR
Patient Weight113
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