MAUDE Adverse Event Report: SOCLEAN, INC. SO CLEAN 2; DISINFECTANT, MEDICAL DEVICES

Model Number SC1200

Patient Problems Headache (1880); Localized Skin Lesion (4542)

Event Date 01/01/2023

Event Type  Injury  

Event Description

I just put (b)(6) 2023 since i can't remember actual dates.I have the so clean 2 and have used it over the last approximately 6 years.I was told at the time that i did not have to manually wash any of my mask or tubing once i got the so clean.I did notice a smell in the mask at times but was told by so clean they may happen and not a problem.Over the past few years at least 2 times a year i would notice this musty smell in my nasal area that would last several days also intermittent headaches, sores in my nasal area.I had no idea based on conversations with so clean that these would be anything to be concerned about.I did ask my doctor about it and they said i could try saline spray to clean my nasal area, since i didn't have a discharge or fever and get a gel to put in my nose for the sores.All of which i did, but the musty smell would still last several days.About 2 months ago while on their website i noticed they had this adapter that i had never seen or heard about.I called and asked if i should get it and i was told no, that is for people that have cpap (continuous positive airway pressure) devices that don't work with the so clean.I feel very let down by so clean and now i am concerned that i have done some lasting damage to my health.

• Brand Name: SO CLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 18311510
• MDR Text Key: 330428685
• Report Number: MW5149127
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: SC1200
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White