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

Patient Problem Bronchitis (1752)

Event Date 08/28/2023

Event Type  Injury  

Event Description

Severe chronic bronchitis.Seems to be caused by the soclean device.

• Brand Name: SOCLEAN
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN INC.
• MDR Report Key: 18537612
• MDR Text Key: 333434964
• Report Number: MW5150517
• 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: 01/15/2024

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2024
• Patient Sequence Number: 1
• Treatment: LISINOPRIL.; METFORMIN.; VENLAFAXINE.; VITAMINS.
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 114 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White