MAUDE Adverse Event Report: Graphic Controls Acquisition 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 Codes	Erythema (1840); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury

• Brand Name: Nissha Medical Technologies
• Common Device Name: ECG Monitoring Electrodes
• Manufacturer (Section D): Graphic Controls Acquisition Corp.; 400 exchange street; buffalo NY 14204
• Manufacturer (Section G): Graphic Controls Acquisition Corp; 400 exchange street; buffalo NY 14204
• Manufacturer Contact: chloe miller ; 400 exchange street; buffalo, NY 14204 ; +1(716)849-6356
• MDR Report Key: 50795167
• Report Number: 1317188-2026-00111
• Device Sequence Number: 10529930
• Product Code: DRX
• UDI-Device Identifier: 10813150020944
• UDI-Public: 10813150020944
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/16/2026
• 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