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

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 05/01/2017

Event Type  Injury  

Event Description

I used the soclean cpap cleaning machine, after i purchased it for (b)(6).It used ozone to cleanse cpap machine.There was ozone residue left in my cpap after using the soclean, and that ozone residue burned my sinuses and lungs.This product is hazardous to people's respiratory systems and it causes pain.It caused me severe pain.This product is unregulated and it should be regulated.I went to the doctor and was told to discontinue use of the soclean machine.

• Brand Name: SOCLEAN CPAP CLEANING MACHINE
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN INC.
• MDR Report Key: 7805317
• MDR Text Key: 118037108
• Report Number: MW5079283
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 40 YR
• Patient Weight: 91