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

Model Number 2

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Peeling (1999); Rash (2033); Tissue Breakdown (2681)

Event Date 07/15/2019

Event Type  Injury  

Event Description

I purchased a so clean 2 machine in (b)(6) 2018 and began using it to clean my cpap machine nightly.Within a few weeks i started to develop sever skin rashes, sores and peeling around my nose.At first, i attributed the rash to one of my masks (i use several for travel, cycle through for cleaning, etc.) i bought several masks from different manufacturers and styles and the problem did not get any better.I though the problem might be with the tubing, which i also replaced, but it did not help.I have a travel machine that i used rarely, so i tried that to eliminate the possibility was with my cpap machine itself.Finally, i tried eliminating the ozone cleaner (so clean 2) and my rashes cleared up within a few nights.I got rid of the soclean 2 machine and haven't used it since.However, a couple of months after i stopped using it, i went on vacation and used my travel mask that i hadn't used in months and there must have been some residual ozone or an ozone-affected substance in that machine because i did develop a slight rash the first night after using that machine.In that case, the rash was only mild and only lasted a couple of nights.I have not experienced any further rashes or adverse affects from any of the same masks, tubing or machines after permanently discontinuing use of the ozone cleaner.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12217434
• MDR Text Key: 263457071
• Report Number: MW5102735
• Device Sequence Number: 1
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 48 YR
• Patient Weight: 177