MAUDE Adverse Event Report: SOCLEAN INC. SO-CLEAN DEVICE #2; DISINFECTANT, MEDICAL DEVICES

Patient Problem Cough (4457)

Event Type  Injury  

Event Description

I got a bad cough from using my so-clean machine.I called so-clean and they gave me my money back for 8-2017 purchase.

• Brand Name: SO-CLEAN DEVICE #2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN INC.
• MDR Report Key: 18650606
• MDR Text Key: 334741903
• Report Number: MW5151083
• 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: 02/01/2024

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Patient Sequence Number: 1
• Treatment: BLOOD THINNERS
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White