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	Rash (2033); Blister (4537); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient reported skin irritation as broken out in blisters, raised red bumps, and a rash.The patient did seek medical treatment and the use of an otc medication.The patient reported that they did not follow proper skin preparation instructions.
Additional Manufacturer Narrative
Lot number provided by the initial reporter was not valid for the part number provided, this will be considered an unknown lot number.Investigation could not be performed.Trending indicates no further action required.

• 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, NM 14204 ; 7165078135
• MDR Report Key: 23542283
• Report Number: 1317188-2025-00051
• Device Sequence Number: 21153258
• 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): 11/13/2025

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/13/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown