MAUDE Adverse Event Report: SO-CLEAN INC. SO-CLEAN; DISINFECTANT, MEDICAL DEVICES

Model Number SO-CLEAN 2

Device Problems Contamination (1120); Material Discolored (1170)

Patient Problems Dyspnea (1816); Headache (1880)

Event Date 01/01/2015

Event Type  Injury  

Event Description

I've been using a so-clean device on my cpap for 5 years.The tubing becomes discolored and i would simply replace.In (b)(6) 2020 i sent my resmed airsense 10 to resmed for repair due to a noisy motor.The unit was repaired at a cost of (b)(6) indicating the damage was due to ozone exposure.Seals were damaged as well as the motor and other parts being contaminated per the invoice from resmed.My wife found the february 2020 fda report on these types of sanitation devices and based on the info i will not be using so -clean moving forward.While i suffer from chronic sinusitis, the condition seems to have worsened over the past 5 years after using so-clean.Congestion, headaches, difficulty breathing at times are all symptoms i've experienced.Fda safety report id# (b)(4).

• Brand Name: SO-CLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SO-CLEAN INC.
• MDR Report Key: 11125207
• MDR Text Key: 225511401
• Report Number: MW5098677
• Device Sequence Number: 1
• Product Code: LRJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/31/2020

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: No Information
• Device Model Number: SO-CLEAN 2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 100