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

Model Number SC1200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discharge (2225); Ulcer (2274)

Event Date 03/09/2019

Event Type  Injury  

Event Description

Purchased "soclean" for use with cpap.Had a small cut on nose.When using the "soclean" to sanitize my cpap, i developed oozing sores on my nose, similar to cold sores.When i traveled for a week and continued to use the cpap but not the "soclean", the sores cleared up.Returned home and used "soclean" and the sores returned.Was on vacation for 2 weeks and the sores cleared up.I returned home and started using the "so clean" and they returned.I can only conclude that it is the "soclean" because i continue to use the cpap when i travel but not the soclean and the sores clear up.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 8555625
• MDR Text Key: 143400900
• Report Number: MW5086202
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SC1200
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 62 YR
• Patient Weight: 85