MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 2; DISINFECTANT, MEDICAL DEVICES

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

Patient Problems Chest Pain (1776); Headache (1880)

Event Date 08/30/2021

Event Type  Injury  

Event Description

Used my soclean 2 and experienced nose and eye irritation also mild chest pain after inhaling fumes that the machine was putting out i guess.Very strong smell.This has lasted for more than a couple of hours but appears to be getting better will not be using the machine anymore.Also, my head hurts.When purchasing this piece of equipment i did not know it was not approved by the federal drug and food administration.

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12413112
• MDR Text Key: 269877202
• Report Number: MW5103665
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): Y
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 95