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

Model Number SOCLEAN 2

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Cancer (3262)

Event Date 01/29/2019

Event Type  Injury  

Event Description

I have been a cpap user for over 10 years.Approx a year ago, i purchased a cpap sanitizer from soclean.It uses ozone to clean the equipment.I don't smoke or drink.I was diagnosed with larynx cancer about six months ago and had radiation treatment at (b)(6).My dr, dr (b)(6) thought it was unusual to develop lyrynx cancer without smoking or drinking.I did some research and found that ozone can cause cancer.I can only tell there was an ozone smell in the equipments hours after i used the unit.In fact the bedroom smelled of it too.It is my belief, that this unit's ozone output caused my cancer.The unit is available for inspection.Document number: (b)(4).Retailer: soclean.Retailer state: (b)(4).Purchase date: (b)(6) 2019, this date is an estimate.

• Brand Name: CPAP CLEANER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 8758398
• MDR Text Key: 150155019
• Report Number: MW5087813
• 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: 05/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SOCLEAN 2
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1