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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); Swelling (2091); Reaction (2414)

Event Date 03/04/2020

Event Type  Injury  

Event Description

Pt called this dme for urgent care due to reactive airway exacerbation and sinus infection diagnosis.Pt was prescribed antibiotics for infection and prednisone for airway swelling.Pt came in and described problem and insisted he cleans his pap equipment regularly but wanted it checked for any problems.Having brought his unit into this dme, upon inspection i noted a common ozone cleaner adaptive lid replacement for his pap humidifier.He stated this was for his so clean device.I then showed him both the resmed amended warranty and an article from (b)(6) reporting on the fda stance of ozone cleaners as well as uv light cleaners.Pt was surprised and stated he will stop use immediately.Pt reported going to urgent care twice more the week of this appt for pulmonary assessment of severe cough and was feeling better after having stopped the ozone cleaning routine within days after that.I have since learned of this service.I am not aware of any specific testing as it is outside of my scope of practice to check.Fda safety report id# (b)(4).

• Brand Name: SO CLEAN OZONE CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC. ; peterborough NH 03458
• MDR Report Key: 9897308
• MDR Text Key: 185710634
• Report Number: MW5093964
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: 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): Other; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 113