MAUDE Adverse Event Report: VIRTU CLEAN \ HEALTHCARE LOGISTICS SYSTEMS VIRTUCLEAN 2.0; DISINFECTANT, MEDICAL DEVICES

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cough (4457)

Event Date 02/25/2021

Event Type  Injury  

Event Description

Chronic debilitating cough; we purchased the virtu clean ozone cpap cleaner towards the end of (b)(6) 2021.By the end of (b)(6) developed a cough.He has had several rounds of antibiotics and x-rays.He has seen a pulmonary specialist and is scheduled for a ct scan.It wasn't until he went to see his sleep study dr.And she told him about the adverse effects of the ozone cleaner.Fda safety report id #(b)(4).

• Brand Name: VIRTUCLEAN 2.0
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): VIRTU CLEAN \ HEALTHCARE LOGISTICS SYSTEMS
• MDR Report Key: 12099172
• MDR Text Key: 259620426
• Report Number: MW5102215
• 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: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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; Disability
• Patient Age: 78 YR
• Patient Weight: 74