MAUDE Adverse Event Report: GRAPHIC CONTROLS ACQUISITION CORP. NISSHA MEDICAL TECHNOLOGIES; ECG MONITORING ELECTRODE

Model Number	A10042-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Itching Sensation (1943); Blister (4537); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A dhr review was completed with no noted nonconformance's 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 reported skin irritation in the form of redness, itching, and blisters/welts.The patient sought medical treatment from their doctor and used an otc medication.The patient reported following proper skin preparation.

• Brand Name: NISSHA MEDICAL TECHNOLOGIES
• 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: 24903280
• Report Number: 1317188-2026-00056
• Device Sequence Number: 9928655
• Product Code: DRX
• UDI-Device Identifier: 20813150020941
• UDI-Public: 20813150020941
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/16/2026

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: Lay User/Patient
• Device Model Number: A10042-10
• Device Catalogue Number: 6500062V
• Device Lot Number: 415325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/16/2026
• 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