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

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).

• Brand Name: SO CLEAN 3
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 13499935
• MDR Text Key: 285408725
• Report Number: MW5107318
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: BENADRYL FOR MY FACE; HYOSCYAMINE; LOMOTIL; TRAZODONE; VIBERZI
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 132 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White