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

Device Problems Chemical Problem (2893); Device Unsafe to Use in Environment (2918); Inadequate Instructions for Non-Healthcare Professional (2956)

Patient Problems High Blood Pressure/ Hypertension (1908); Dizziness (2194); Chemical Exposure (2570)

Event Date 05/04/2021

Event Type  Injury  

Event Description

Blood pressure soared; we purchased a soclean ii to clean husband's cpap machine.After using only once, plus a test run, he suffered toxic ozone exposure.He felt woozy; he is a heart patient also on blood pressure medication.I took his blood pressure.It was 188/118! we took his blood pressure every 5 minutes for 45 minutes.It went down a little but was still in the 170s/100-110s.We called his primary physician who saw him immediately.He listened to the heart, did an ekg, took blood pressure.He told us that ozone can definitely raise blood pressure.The only contraindications list for this product is in the manual inside the box which you only see after purchase.The doctor told us to stop using and immediately return it, which we did.Now i read on the fda website that this machine is not approved for use in the us.Also, continued use of both the ozone cleaners and even the ultraviolet cleaners can damage the machine, to say nothing of the damage to the patient's health.After we returned from the doctor, even after opening windows and running fans, i couldn't believe how saturated the air was in the bedroom where both the cpap and soclean ii were located.There should be some sort of black box warning or, better yet, a very public warning as to just how dangerous this product is.A person with a diminished sense of smell could even succumb to the ozone with continued use.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN II
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 11825009
• MDR Text Key: 250884274
• Report Number: MW5101354
• Device Sequence Number: 1
• Product Code: LRJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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): Other
• Patient Age: 76 YR
• Patient Weight: 93