MAUDE Adverse Event Report: SOCLEAN INC. SOCLEAN2; DISINFECTANT, MEDICAL DEVICES

Model Number SOCLEAN2

Device Problem Nonstandard Device (1420)

Patient Problems Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 12/20/2022

Event Type  Injury  

Event Description

About ten years ago i began using a philips resporonics cpap.After the first couple of years i bought a soclean attachment to the respironics device to assist in cleaning the cpap.So after i began to develop a chronic dry cough.This cough persisted to the time i stopped using the soclean device on (b)(6) 2022.So after the cough dissipated and then stopped.I participated in the philips recall of the respironics cpap a year or two ago after reading that the soclean device was eroding the foam filter in the respironics device.That device was replaced by a philips dreamstation2 cpap.However my chronic cough persisted.It occured to me that perhaps there was something else to do with the soclean device that was contributing to my persistant dry cough.I decided to disconnect the soclean device entirely from my cpap and as i mentioned the coughing quickly dissipated and stopped.I used the soclean for about 8 years and i am afraid it has caused damage to my lungs as i have had a susceptability to respiratory problems starting around the time i started using the device.I am also concerned the issue with the philips respironic device in conjunction with the soclean has caused damage to my lungs due to the foam filter issue.I called philips and they said that they no longer recommended the use of the soclean with any of their devices and if i had a concern to contact the fda.I'd like to know if the fda conducted tests of these two products being used together and what the results of those tests might be.If these tests prove that either the foam or the ozone used by the soclean caused physical harm what if any litigation is ongoing for those that may have suffered damage.I'd also like to help the fda in any way i can as they examine the physical impact of these devices to people's health.

• Brand Name: SOCLEAN2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN INC.
• MDR Report Key: 16204760
• MDR Text Key: 307824525
• Report Number: MW5114376
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• 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: 01/16/2023
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOCLEAN2
• Device Catalogue Number: SC1200-S10K
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: NEXIUM; TAMSULOSIN; VITAMIN SUPPLEMENT
• Patient Outcome(s): Disability
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White