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 01/19/2024

Event Type  Injury  

Manufacturer Narrative

File a 30-day mdr.An assessment was conducted.The event is still considered reportable under fda's regulation.Reporting out of an abundance of caution.Information regarding the potential underlying cause(s) of the adverse event remains unclear as to whether the event is directly linked to the use of soclean.Reporting is conducted as part of due diligence.

Event Description

Customer reports rash on face from unknown source.Md prescribed a cream.

• 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: 18704308
• MDR Text Key: 335368776
• Report Number: 3009534409-2024-00019
• 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: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• 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: 01/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2022
• 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: Female