MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL, LLC RHYTHMLINK®; ELECTRODE, CUTANEOUS

Model Number	DC2415
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: pt seen at bedside in skin response for evaluation of suspected pressure injury to forehead (top).Injury due to eeg [(electroencephalogram)] lead.Injury was found after egg removal today.Wound appears as shallow tissue loss with pink wound base.Edges are defined and in the shape of eeg lead.This injury is classified as a stage 2 pressure injury due to mechanical device.Recommend leaving area ota [open to air] and continue to monitor area.Wound team will continue to follow pt.

• Brand Name: RHYTHMLINK®
• Common Device Name: ELECTRODE, CUTANEOUS
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL, LLC; 1140 first st. south; columbia SC 29209
• MDR Report Key: 24002646
• Report Number: 24002646
• Device Sequence Number: 16079487
• Product Code: GXY
• UDI-Device Identifier: 10816312023654
• UDI-Public: (01)10816312023654
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025
• Report Date (Section F): 12/22/2025

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 Model Number: DC2415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Date Report Sent to FDA: 12/22/2025