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

Model Number SC1200

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Fatigue (1849)

Event Date 03/12/2018

Event Type  Injury  

Event Description

After approximately 3 months of using soclean 2 cpap cleaner i noticed i was getting sick, started having chest pains for short periods of time each day and felt tired all the time.After research of the product, found it uses ozone to disinfect and found i had most of the symptoms of excess ozone in my system.After 3 days of not using it i am feeling much better with no instances of chest pain and my cold is going away along with my lungs clearing up.I will be seeing my doctor in 2 weeks to be referred to a cardiologist for assessment.

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN INC.
• MDR Report Key: 7352173
• MDR Text Key: 102996599
• Report Number: MW5075954
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SC1200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 145