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

Patient Problems Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 06/01/2023

Event Type  Injury  

Event Description

Patient called to report an issue with her soclean 2 device.Patient stated for the last 6 months she has been experiencing a rash which she believes to be related to or caused by the device.She stated she's developed a rash and some kind of reaction along the side of her nose.She is unsure what exactly is causing it and what to do about it.

• Brand Name: SOCLEAN 2
• Type of Device: DISINFECTANT, MEDICAL DEVICES
• Manufacturer (Section D): SOCLEAN, INC.
• MDR Report Key: 18290948
• MDR Text Key: 330220179
• Report Number: MW5149005
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female