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

Device Problems Nonstandard Device (1420); Device Emits Odor (1425)

Patient Problem Headache (1880)

Event Type  malfunction  

Event Description

I have a so clean product and have received a recall for the machine (voluntary).I have headaches, bad smell out of the machine i am afraid of the more side effects customer service (b)(4).Fda safety report (b)(4).

• Brand Name: SO CLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 12180673
• MDR Text Key: 262244097
• Report Number: MW5102580
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 00187293000860
• UDI-Public: 187293000860
• 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: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1