MAUDE Adverse Event Report: GRAPHIC CONTROLS ACQUISITION CORP. LSI; ECG MONITORING ELECTRODE

Model Number	LSI-E5700
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	03/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A dhr review was completed with no noted nonconformances or anomalies during production.The materials that are patient contacting are non-cytotoxic, non-sensitizing and non-irritating.Samples were not available for further evaluation.
Event or Problem Description
Patient stated the electrodes used during the graded stress test caused redness on the outer ring of the electrodes not where the gel is on the inside.Patient had redness and multiple small scabbed areas.Patient consulted a physician and was prescribed a cream medication.The patient's skin was not prepped.

• Brand Name: LSI
• Common Device Name: ECG MONITORING ELECTRODE
• Manufacturer (Section D): GRAPHIC CONTROLS ACQUISITION CORP.; 400 exchange street; buffalo NY 14204
• Manufacturer Contact: amy intini ; 400 exchange street; buffalo, NY 14204 ; 7165078135
• MDR Report Key: 25171812
• Report Number: 1317188-2026-00070
• Device Sequence Number: 10190367
• Product Code: DRX
• UDI-Device Identifier: 10813150021934
• UDI-Public: 10813150021934
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: LSI-E5700
• Device Catalogue Number: 6500895V
• Device Lot Number: 399276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown