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 Code	Burning Sensation (2146)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported a burning sensation and hives.The patient sought medical treatment and was prescribed a topical anti-inflammatory medication.The patient confirmed following the 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: 50732942
• Report Number: 1317188-2026-00106
• Device Sequence Number: 18799945
• Product Code: DRX
• UDI-Device Identifier: 10009336008343
• UDI-Public: 10009336008343
• 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: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2026
• 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: 09/11/2026