MAUDE Adverse Event Report: GRAPHIC CONTROLS ACQUISTION CORP NISSHA MEDICAL TECHNOLOGIES; ECG MONITORING ELECTRODES

Model Number	A10042-10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	11/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A dhr review was completed for the lot in question.No manufacturing nonconformance's identified and no reported problems with the raw material used.Biocomp reports were reviewed and product tests negative for cytoxicity, skin irritation and sensitization.No further action required.
Event or Problem Description
The patient reported on (b)(6) 2025, that he experienced skin irritation when using the flexwire device.The patient reported the skin irritation as a burning (sensation), (skin) irritation, itching, and raised skin.The patient reported that he did seek medical treatment and sought the use of prescribed medication to treat the skin irritation.The patient reported the prescribed medication used as an oral antihistamine.The patient reported that he did not discontinue the use of the device.The patient reported that he did follow the skin prep instructions.

• Brand Name: NISSHA MEDICAL TECHNOLOGIES
• Common Device Name: ECG MONITORING ELECTRODES
• Manufacturer (Section D): GRAPHIC CONTROLS ACQUISTION CORP; 400 exchange street; buffalo NY 14204
• Manufacturer Contact: juliana melito ; 400 exchange street; buffalo, NY 14204
• MDR Report Key: 23872568
• Report Number: 1317188-2025-00071
• Device Sequence Number: 14590605
• Product Code: DRX
• UDI-Device Identifier: 20813150020941
• UDI-Public: 20813150020941
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 399758
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Male