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

Device Problems Material Fragmentation (1261); Nonstandard Device (1420); Patient-Device Incompatibility (2682)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 02/07/2021

Event Type  Injury  

Event Description

As i was going to fill my water reservoir on my philips dream station cpap machine.I found numerous particles floating in the water.I recently found out that there is a recall on the dream station machine due to issues with the insulation breaking down and entering the water chamber and hose.I had used the so clean device on my cpap machine and had a serious breathing issues shortly after first using the device and stopped using the so clean on cpap machine.I have had chronic sinus issues most of 2019 and 2020.When i stopped using the dream station in (b)(6) 2021 my sinus issues resolved itself.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN FAMILY OF PRODUCTS
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12506508
• MDR Text Key: 272684265
• Report Number: MW5104082
• Device Sequence Number: 2
• 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: 09/16/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 59 YR
• Patient Weight: 141