MAUDE Adverse Event Report: SOCLEAN, INC. SO CLEAN 2; DISINFECTANT, MEDICAL DEVICES

Model Number SC1200

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Pain (1994); No Code Available (3191)

Event Date 04/18/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 i woke up coughing and a bad pain in my chest.I also had pain on my right side.The pain hurt every time i coughed.I was unable to take deep breath.I didn't know what was wrong.I informed my wife about the problem and she advised me to take some nightquil to see if it would help with the coughing.I stop using my bipap for two days.The pain was still there but not as intense.On thursday, (b)(6) 2020 i had a scheduled appointment with my sleep doctor.I began telling him the pain in my chest and breathing problem.He asked me if i was using a so clean2 unit to clean my sleep equipment.I told him yes; he immediately informed me about an fda february 2020 consumer alert about my soclean unit and recommended that i stop using the unit immediately and until further notice.I did not know that the so clean 2 machine was not fda approved since there were so many tv info commercial and website recommendations.I am still having breathing problems today.Fda safety report id# (b)(4).

• Brand Name: SO CLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC. ; peterborough NH
• MDR Report Key: 10009164
• MDR Text Key: 189496613
• Report Number: MW5094303
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 00187293000860
• UDI-Public: 187293000860
• 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: 04/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SC1200
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 67 YR
• Patient Weight: 116