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

Model Number SOCLEAN 2

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

Patient Problems Pain (1994); Skin Irritation (2076)

Event Date 07/01/2018

Event Type  No Answer Provided  

Event Description

Caller says that the product is used to clean his cpap machine.Caller says that on the side of this nose he gets rough and irritated skin that is painful after using the product.The irritation goes away when he does not use the machine and reappears anytime he uses it.Caller is concerned that the device is damaging his lungs.Retailer: (b)(6).Purchase date: (b)(6) 2018 - this is an estimate.Incident location: (b)(6).(b)(4).

• Brand Name: SOCLEAN 2 CLEANING DEVICE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 8496305
• MDR Text Key: 141442976
• Report Number: MW5085657
• 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: Other
• Type of Report: Initial
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Device Operator: No Information
• Device Model Number: SOCLEAN 2
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 0