MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2 CPAP CLEANER AND SANITIZER; DISINFECTANT, MEDICAL DEVICES

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Headache (1880); Pleural Effusion (2010); Cough (4457); Wheezing (4463)

Event Date 04/20/2021

Event Type  Injury  

Event Description

The above date is the first date when i sought care for worsening asthma symptoms.I purchased and used soclean 2 cpap sanitizer in (b)(6) 2020 to clean my cpap daily.Since its use, my asthma symptoms have worsened to the point that i'm now on parenteral therapy and continue to daily symptoms of cough, wheezing and productive cough.I've had nearly daily headaches.I have only recently discovered the health harms that can occur with exposure from "activated oxygen" from the device.It took my cpap malfunctioning for the past 4-6 months to bring my attention to looking into the soclean 2 device as the cause of the problems.I had to go the ed for pleuritic chest pain recently, and continue to have some intermittently.I am ashamed since i am a family medicine physician that i didn't know this before, or sooner, but i think the pandemic has kept my attention from the warnings about the dangers of this treatment of cpap equipment and exposure to users.I have discontinued use of the malfunctioning cpap and soclean 2 sanitizer and started to use an older model cpap.My hope is the symptoms will improve without ongoing exposure to the ozone gases.Cxr demonstrated bibasilar opacities with trace left pleural effusion, and right basilar atelectasis.Decrease lung volumes.Fda safety report id #:(b)(4).

Event Description

The above date is the first date when i sought care for worsening asthma symptoms.I purchased and used soclean 2 cpap sanitizer in (b)(6) 2020 to clean my cpap daily.Since its use, my asthma symptoms have worsened to the point that i'm now on parenteral therapy and continue to daily symptoms of cough, wheezing and productive cough.I've had nearly daily headaches.I have only recently discovered the health harms that can occur with exposure from "activated oxygen" from the device.It took my cpap malfunctioning for the past 4-6 months to bring my attention to looking into the soclean 2 device as the cause of the problems.I had to go the ed for pleuritic chest pain recently, and continue to have some intermittently.I am ashamed since i am a family medicine physician that i didn't know this before, or sooner, but i think the pandemic has kept my attention from the warnings about the dangers of this treatment of cpap equipment and exposure to users.I have discontinued use of the malfunctioning cpap and soclean 2 sanitizer and started to use an older model cpap.My hope is the symptoms will improve without ongoing exposure to the ozone gases.Cxr demonstrated bibasilar opacities with trace left pleural effusion, and right basilar atelectasis.Decrease lung volumes.Fda safety report id #:(b)(4).

• Brand Name: SOCLEAN 2 CPAP CLEANER AND SANITIZER
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 13578943
• MDR Text Key: 285995733
• Report Number: MW5107591
• 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: 02/16/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALBUTEROL INHALER; CELECOXIB; FAMOTIDINE; FLUTICASONE/SALMETEROL 500/50 INHALER; LEVOCETIRIZINE; LOSARTAN ; SEMAGLUTIDE ; TADALAFIL ; TOPIRAMATE; TRIAMINCIOLONE NASAL SPRAY; XOLAIR
• Patient Outcome(s): Disability
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White