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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/05/2021

Event Type  Injury  

Event Description

Er visit, poor chest ct; i have used a soclean device since purchasing a cpap two years ago.During an er visit for excruciating rib pain, i had a ct of my chest.It showed several unusual changes in my lungs that could indicate chronic bronchitis or sarcoidosis.I personally believe the culprit is the soclean device and depending on it to clean/sanitize my equipment for the past two years.I have stopped using the device and am hand-washing the tubing and mask.My breathing is improving some how.It has been 19 days since i stopped using it.Fda safety report id # (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN INC
• MDR Report Key: 11392073
• MDR Text Key: 234269060
• Report Number: MW5099680
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 87