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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Nodule (4551)

Event Date 01/24/2023

Event Type  Injury  

Event Description

I have been using the soclean machine to disinfect my cpap equipment for approximately 3 1/2 years.In (b)(6) of this year, i had a head and neck ct (computed tomography) scan for a non-lung related condition.The radiologist noticed a nodule on the upper lobe of my left lung.A pet (positron emission tomography) scan was ordered to view both lungs.I have multiple nodules on both sides and one in particular "lit up".I have an appointment with a pulmonologist on "(b)(6)." i'm very suspicious of the soclean causing my lung issues.I have never been a smoker.If you would like, i can keep you updated on my progress.Thank you for your time.

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 16446509
• MDR Text Key: 310367489
• Report Number: MW5115236
• 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: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White