MAUDE Adverse Event Report: MEDICO ELECTRODES INTERNATIONAL LTD NISSHA MEDICAL TECHNOLOGIES; ECG MONITORING ELECTRODES

Model Number	A10091-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No lot number was provided, therefore unable to confirm if this report is related to nissha product, however reporting out of an abundance of caution.
Event or Problem Description
The patient reported experiencing an allergic reaction, bleeding/discharge, and open sores.Medical treatment was sought and the patient was treated with a prescription topical anti-inflammatory medication.The patient reported following the recommended skin preparation steps.

• Brand Name: NISSHA MEDICAL TECHNOLOGIES
• Common Device Name: ECG MONITORING ELECTRODES
• Manufacturer (Section D): MEDICO ELECTRODES INTERNATIONAL LTD; plot 142a/11, 12, 27, 28 & 29; economic zone noida, uttar pradesh 20130 5; IN 201305
• MDR Report Key: 25906101
• Report Number: 1317188-2026-00089
• Device Sequence Number: 20294040
• Product Code: DRX
• UDI-Device Identifier: 50009336008341
• UDI-Public: 50009336008341
• 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: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2026
• Report Date (Section F): 07/22/2026

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: A10091-30
• Device Catalogue Number: 32028476
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/22/2026
• Event Location: Other
• Date Report to Manufacturer: 07/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2026
• 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
• Date Report Sent to FDA: 07/22/2026