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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOCLEAN, INC. SO CLEAN 3 DISINFECTANT, MEDICAL DEVICES

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SOCLEAN, INC. SO CLEAN 3 DISINFECTANT, MEDICAL DEVICES Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bronchitis (1752); Itching Sensation (1943); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Event Date 02/02/2022
Event Type  Injury  
Event Description
I have sleep apnea, and use a res med device with a full mask. I have used one for 3 years, but i am bad at cleaning the parts. I have been getting frequent sinus infections that become bronchitis. I bought a so clean 3 device after watching a commercial to help me keep my parts clean. After 2 weeks of usage, i began getting a red rash on my face where the mask sits. That was on feb. 1, 3 days later my rash is swollen, open sores, and seeping. My face hurts, burns, and itches. I have stopped using the soclean device. I am seeing a doctor for treatment of my reaction. My face feels awful. Fda safety report id # (b)(4).
 
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Brand NameSO CLEAN 3
Type of DeviceDISINFECTANT, MEDICAL DEVICES
Manufacturer (Section D)
SOCLEAN, INC.
MDR Report Key13499935
MDR Text Key285408725
Report NumberMW5107318
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 02/04/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/08/2022
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: 02/08/2022 Patient Sequence Number: 1
Treatment
BENADRYL FOR MY FACE; HYOSCYAMINE; LOMOTIL; TRAZODONE; VIBERZI
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