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

Model Number A10091-30

Device Problem Insufficient Information (3190)

Patient Problem Burning Sensation (2146)

Event Type  Injury  

Event Description

Patient reported experiencing severe skin irritation while wearing the patch attached to the black lead of the lwa.Patient mentioned burning sensation, scarring and raised lymph nodes.Patient reported that the collar bone to armpits were swollen.Patient also had pain in the shoulder to elbow and from back of the armpit area.Patient stated the black lead was hotter than normal to the touch.Patient reported that the electrode attached to the black lead was melted and the device was not being charged.Patient went to the emergency room (er) and was given antibiotics.The device was not accidently damage during usage.Patient has no implantable devices.Patient states no skin irritation or allergies.

Manufacturer Narrative

No lot number or samples were provide so no dhr review or thorough investigation could be completed.A review of the biocompatability report states patient interacting materials are non-cytotoxic, non-sensitizing, and non-irritating.

• 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: 17414071
• MDR Text Key: 320019025
• Report Number: 1317188-2023-00009
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Report Sent to FDA: 07/28/2023
• Distributor Facility Aware Date: 07/07/2023
• Date Report to Manufacturer: 07/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female