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

Model Number SOCLEAN

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

Patient Problems Asthma (1726); Chest Tightness/Pressure (2463)

Event Date 11/04/2019

Event Type  Injury  

Event Description

Increased coughing, tightness of chest, wheezing, after using product -soclean (for home automated cpap equipment sanitizer using ozone cartridges).I've detected a white, powdery residue sometimes after using this product.No manual came with the product.It was shown to me how to use it by a respiratory tech.There are no manuals/or disclosures on adverse effects using this product.I went for medical help at urgent care due to an asthma attack.Fda safety report id# (b)(4).

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 9328395
• MDR Text Key: 166791000
• Report Number: MW5091097
• 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: 11/13/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SOCLEAN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR