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

Device Problem Device Emits Odor (1425)

Patient Problems Aspiration/Inhalation (1725); Chest Pain (1776); Dyspnea (1816); Headache (1880); Dizziness (2194); Cough (4457)

Event Date 01/11/2021

Event Type  Injury  

Event Description

I had difficulty breathing, chest pain, and experienced some headaches and dizziness after using the ozone cleaner for my cpap.I did use it in the morning (every other day) for cleaning (from 10 am-noon), in a very large bedroom with ample airflow (the room is approximately 18x20 square feet), but soon learned that i could not enter my bedroom while the machine was working.I also found that i had to run the machine for about 5 minutes in the evening before putting it on in order to "clear" it from all the ozone smell.But i still had some residual coughing when i first put it on and i could taste the ozone flavor in my mouth.At the time, i thought i was just highly sensitive, as i do have severe allergies, and that each time, i was having a difficult time adjusting to the cpap machine for the first few minutes.After the fda warnings, i stopped using the ozone machine, and found that i no longer felt dizzy, had any headaches, difficulty breathing, or had any "warm up" issues with my cpap machine.What i now know is that all of those symptoms were directly related to the ozone machine.The issue that is really galling for me is that apria, my respiratory therapy company, actually sold the machine to me.I called them to ask a question to make sure that i was following all of the directions for cleaning exactly as i needed to, because i wanted to make sure that i would not have any mold or mildew left in my machine.I am very allergic to mold and mildew, and, in fact, was treated many years ago, for a dangerous, but difficult to diagnose allergic reaction to water in an aquarium.So, i really wanted to get the cpap cleaning right.When the representative suggested the ozone cleaner as a water-free alternative (even though it was $(b)(6) out of pocket), it seemed like a safe alternative.Since i had only had the cpap for a few weeks, i had no way of knowing that it would be the cause of all of my symptoms.On several occasions, i had to use my inhaler in order to breathe, and i also underwent a full cadre of cardiac testing because of increased chest pain after beginning to use the cpap.No one could understand why the cpap would cause such severe and sudden chest pain like i was describing.Looking back on all of this now, in light of the fda's newfound concerns, i want to weigh in and share this data.As a 63 year old woman, i am concerned that the ozone cleaner is at fault, and that i was a victim of false medical sales that prey on vulnerable people.Customer representatives for medical supply companies who sell products that require prescriptions should not be alternatively be pushing other items that are not medically in the best interest of their clients.Thank you for reviewing this material and looking out for the consumer.Fda safety report id # (b)(4).

• Brand Name: OZONE CLEANER FOR CPAP
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 14644617
• MDR Text Key: 293832415
• Report Number: MW5110220
• 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: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ADDERALL; SYNTHROID; VITAMIN D; ALLEGRA; AMBIEN; NORVASC; SINGULAIR; TOMOMAX; VERAPAMIL; VITAMIN B; VITAMIN C
• Patient Outcome(s): Other; Disability
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White