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

Patient Problem Insufficient Information (4580)

Event Date 01/01/2020

Event Type  malfunction  

Event Description

My soclean2 device, purchased on 2019-10-30, left ozone odor in the tubing of my resmed 10 cpap machine.I rigged up a small blower to flush the tubing and mask (while not connected to the cpap machine) with fresh air.This would make it useable after an hour or so.This difficulty is not what i expected from the soclean device and i stopped using it.

• Brand Name: SOCLEAN2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN2, INC.
• MDR Report Key: 18573868
• MDR Text Key: 333722327
• Report Number: MW5150678
• 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: 01/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2024
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White