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

Model Number A10091-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 02/09/2022

Event Type  Injury  

Event Description

The patient consulted a clinician and complained that the device electrodes were making his skin bumpy and bloody.The physician prescribed hydrocortisone ointment to apply to the affected area.The patient decided to return the actual device early and did not continue enrollment.The patient did not return electrodes.The patient did advise they have sensitive skin.He electrode part number is 32028476, a10091-30 and the lot number is unknown.

• Brand Name: NISSHA MEDICAL TECHNOLOGIES
• Type of Device: ECG MONITORING ELECTRODE
• 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: 14042276
• MDR Text Key: 288784694
• Report Number: 1317188-2022-00006
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2022,03/05/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: A10091-30
• Device Catalogue Number: 32028476
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2022
• Distributor Facility Aware Date: 03/07/2022
• Event Location: Other
• Date Report to Manufacturer: 04/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male