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

Model Number	A10091-30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Itching Sensation (1943); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A dhr review was completed with no noted nonconformances 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
The patient reported skin irritation in the form of burning sensation, itching, and rawness with no open skin.The patient sought medical treatment and was prescribed a topical steroid.Patient recommended following proper skin preparation steps.

• Brand Name: NISSHA MEDICAL TECHNOLOGIES
• Common Device Name: ECG MONITORING ELECTRODE
• Manufacturer (Section D): MEDICO ELECTRODE INTERNATIONAL LTD; plot 142a/11, 12, 27, 28 & 29; economic zone noida, uttar pradesh 20130 5; IN 201305
• MDR Report Key: 25856418
• Report Number: 1317188-2026-00087
• Device Sequence Number: 5456468
• 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
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2026
• Report Date (Section F): 07/17/2026

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: 23625V13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/18/2026
• Event Location: Other
• Date Report to Manufacturer: 07/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/17/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/17/2026