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

Device Problems Melted (1385); Nonstandard Device (1420); Particulates (1451)

Patient Problems Apnea (1720); Pain (1994)

Event Date 03/01/2020

Event Type  Injury  

Event Description

Dear sir or madam: for approximately a few weeks, around on (b)(6) 2021 time frame, i'm waking, in the morning, with a ache/pain in both lung.It would go away during the day, and then return the next morning.I did not realize at the time that there was a problem with the use of a soclean device with my dreamstation.I use my cpap religiously.Over a year's time, the reports will show that i use my cpap nearly every day, if not every day.Rarely will i not use it.So when i was made aware of the cpap recall, i became concerned because i did recall the pain that i was receiving in my chest.I was made aware of the melting foam issue.And i did recall seeing small, black foam pieces, in my mask.When i was first issue a cpap, my doctor said that my sleep apnea was rated as severe.I really needed to be using it all of the time.So i was in a tough position.I needed to use the machine.So i found a youtube video on how to remove the foam.The foam was successfully removed and i have kept it.It is saved in a zip-lock bag, it is in a gooey, melted state.I have been waiting for a replacement cpap machine since (b)(6) 2021.I purchased this machine with my own money, using my medical fsa account.I spent just a little over (b)(6) on a machine and machine specific batter.However, i decided to put the device in the corner because i am still concerned that it is not safe.Anyway, i just wanted you to know that there is a different side to this story.I have read where philips is making it sound like they are angels and their equipment is in perfect order.In my specific case, the foam was melting and worse, it was getting blown into my mask.I was puzzled by it, thinking the local air must have somehow gotten dirty.If you would like to look at it and get a sample, let me know.I do live in the (b)(6) area.Very respectfully, (b)(6).Reference report mw5115393.

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 16477643
• MDR Text Key: 310732512
• Report Number: MW5115394
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian