MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2; DISINFECTANT, MEDICAL DEVICES

Model Number SO CLEAN 2

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Fever (1858); Pneumonia (2011); Vomiting (2144); Chills (2191)

Event Date 07/03/2021

Event Type  Injury  

Event Description

Began using the so clean 2 cpap ozone cleaner on wednesday, (b)(6).On saturday, (b)(6), my mom began throwing up, running a fever 100+, chills, and labored breathing.After continuing to throw up for 6 hours, she was taken by ambulance to the er where xray's showed pneumonia.She was given iv antibiotics and fluids and release to go home with oral antibiotics - they felt at (b)(6), she would be safer at home than in the hospital with the chance of being exposed to covid.Follow up visit with her pulmonary internist, she was told to immediately stop using the so clean 2.Showed her the fda article about stopping the use of the ozone cleaners.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12275836
• MDR Text Key: 265204472
• Report Number: MW5102970
• Device Sequence Number: 1
• Product Code: LRJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SO CLEAN 2
• Device Catalogue Number: SC1200-SB
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 75