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

Device Problems Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problem Cough (4457)

Event Date 07/01/2021

Event Type  Injury  

Event Description

Used cpap since 2001.Changed to phillips respironics 2018.Bought soclean ozone cleaner 2019.Developed cough gradually over time.Became a problem spring 2021.Noticed news item about recall of my cpap machine summer 2021.Consulted with my pulmonary doctor.Chest x-ray taken and was unremarkable.Discontinued my cpap and soclean.Returned to earlier model cpap.Cough went away in three weeks.Feel better now.

• Brand Name: SOCLEAN OZONE CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12336708
• MDR Text Key: 267264477
• Report Number: MW5103299
• Device Sequence Number: 2
• Product Code: LRJ
• Combination Product (y/n): Y
• 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: 08/14/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 95