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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Fatigue (1849); Inflammation (1932); Alteration In Body Temperature (2682)

Event Date 01/09/2020

Event Type  Injury  

Event Description

Had been diagnosed with bronchitis end of (b)(6) 2019.Bought a soclean 2 hoping it would help me that arrived january 5, 2020.With use, i always smelled in our bedroom ozone and within my cpap gear.Every week i felt exhausted, chills (no high temperature), cough and pain in chest.This would come and go weekly and anytime i tried to exercise it seemed to come back.I stopped using the soclean in late (b)(6) but symptoms persisted.In early (b)(6) i visited a doctor whom thought it was asthma and put me on an inhaler plus we scheduled a visit with a pulmonologist since i did not believe it was asthma since i had never had it and had been running over 5 miles at a time before getting sick.The pulmonologist thought it could be rhinitis and lpr since i told him the inhaler didn't seem to do anything.Numerous tests on lungs were done and a visit to a ent specialist on (b)(6) who put me on medication for lpr and rhinitis.Cat scan results shows mild thickening of esophagus and mild interaction in a mosaic pattern in my upper airways.Now, as of (b)(6), i have been very careful in what i do to not irritate my lungs.It did not seem the meds helped much but i do finally feel less pain in my chest and not nearly as exhausted.But i can still feel something in my upper lungs like an itch and heaviness.Almost like taking a cold breath.Reason for use: cpap cleanliness.

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 10028369
• MDR Text Key: 190180229
• Report Number: MW5094382
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): Y
• 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: 05/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 46 YR
• Patient Weight: 113