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

Device Problems Device Emits Odor (1425); Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Myocardial Infarction (1969); Pneumonia (2011)

Event Date 02/02/2019

Event Type  Injury  

Event Description

In (b)(6) 2019 the reporter purchased soclean for herself and her son.At the end of (b)(6) 2019, the reporter noticed a smell from her device and begain to have severe coughing.Her son noticed the smell from his device as well and stopped using it.On (b)(6) to (b)(6) 2019 the reporter had acute exacerbation of asthma, heart attack, pneumonia, shortness of breath, and wheezing.She reports that she has been on and off again taking antibiotic therapy and steroid treatment.On her frequent appointments to the doctor due to her symptoms she inquired about the smell coming from her soclean device and her doctor told her that it would be fine to use.She also, asked after reading about the ozone that is coming from the device if it would cause her an exacerbation of her asthma or for her lung disease to get worse.She continued to use the device until (b)(6), she was sick again and the doctor told her that she maybe having a reaction from the ozone of the soclean.The reporter called the manufacturer to report that there was no warning label for people who have a health history respiratory illness such as hers not to use this device because of the ozone that it emits.Soclean told her that they would send her packaging to return the devices.She has yet to receive return packaging.

• Brand Name: SO CLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 9962229
• MDR Text Key: 187861329
• Report Number: MW5094145
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/14/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 70