MAUDE Adverse Event Report: SOCLEAN, INC. SOCLEAN 3; SLEEP EQUIPMENT MAINTENANCE SYSTEM

Model Number SC1400

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Date 03/08/2024

Event Type  Injury  

Event Description

Customer reports rash on face where the mask sits.Dermatologist seen.Received steroid cream.

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.Reporting for due diligence.It is pertinent to acknowledge that the customer expresses a desire to persist with the utilization of the soclean and has been provided with troubleshooting protocols to enhance hand hygiene practices.The client asserts in the clinical inquiry that the origin of the rash was presumed to be associated with the pap mask; however, uncertainty persists regarding the potential contribution of the soclean to the presented issue.

• Brand Name: SOCLEAN 3
• Type of Device: SLEEP EQUIPMENT MAINTENANCE SYSTEM
• Manufacturer (Section D): SOCLEAN, INC.; 1 vose farm road; peterborough NH 03458
• Manufacturer (Section G): SOCLEAN, INC.; 1 vose farm road; peterborough NH 03458
• Manufacturer Contact: jessica wilson ; 1 vose farm road; peterborough, NH 03458 ; 6033712570
• MDR Report Key: 18914879
• MDR Text Key: 337792571
• Report Number: 3009534409-2024-00027
• Device Sequence Number: 1
• Product Code: LRJ
• UDI-Device Identifier: 00858242007147
• UDI-Public: (01)00858242007147(21)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SC1400
• Device Catalogue Number: SC1400
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male