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

Model Number 32028476

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/17/2021

Event Type  Injury  

Event Description

Lifewatch reported to nmt on (b)(6) 2022 that the patient of advanced age called lifewatch to report she had experienced an allergic reaction with the vermed/nissha electrode used and received prescriptive treatment.It was mentioned that the patient had a known allergy to adhesives.The lot number used was 49220v13.The patient consulted a clinician and presented with a mild itch, red aggravated circles and pimples where the electrode was located on this skin.The physician prescribed a topical anti-fungal cream to apply to the affected area.The patient was provided with a different type of electrode to continue enrollment.

• Brand Name: NISSHA MEDICAL TECHNOLOGIES
• Type of Device: ECG MONITORING ELECTRODES
• Manufacturer (Section D): MEDICO ELECTRODES INTERNATIONAL LTD; plot 142a/11, 12, 27, 28 & 29; economiic zone; noida uttar, pradesh 20130 5; IN 201305
• MDR Report Key: 13456380
• MDR Text Key: 287421423
• Report Number: 1317188-2022-00003
• 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: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 32028476
• Device Catalogue Number: A10091-30
• Device Lot Number: 49220V13
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/07/2022
• Event Location: Home
• Date Report to Manufacturer: 02/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other