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

Model Number SC: 12001907205029

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

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Rash (2033); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2020

Event Type  Injury  

Event Description

I have been using the soclean product to clean my c-pap machine for approximately 6-9 months.At first, i had no issues.Then around approximately late (b)(6) or early (b)(6) of 2020, i began experiencing a bad rash on my face at areas that came in direct contact with my c-pap machine which was being cleaned daily by the soclean machine.The rash was bright red and began to dry my skin severely and cause a lot of white flaking.At my mouth area, i have developed sores that bleed.I have discontinued use of the soclean product.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 11108030
• MDR Text Key: 225091358
• Report Number: MW5098621
• 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: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SC: 12001907205029
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 95