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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bronchitis (1752); Burning Sensation (2146)

Event Date 09/01/2020

Event Type  Injury  

Event Description

Severe bronchitis for months; i started using an ozone gas (soclean) to disinfect my cpap.After a month or so i developed bronchitis.After 4 months i am very ill.Can barely speak.Lungs feel like they are on fire.X-ray and blood work are ok.Going for ct scan next.I discontinued use of the ozone a couple weeks ago, but symptoms keep getting worse.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 11087037
• MDR Text Key: 224402639
• Report Number: MW5098549
• 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
• Type of Report: Initial
• Report Date: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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; Disability
• Patient Age: 50 YR
• Patient Weight: 113