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

Model Number A10091-30

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Date 08/08/2023

Event Type  Injury  

Event Description

It was reported that the patient has minor peeling of the skin from the electrode.Originally the patient did not seek medical attention and followed the skin prep of soap, water and drying with a cloth.The patient paused service and flex was order.A few days later the patient reported that their skin was red, inflamed and itchy.The patient had a rash on torso and was monitoring.The patient started taking benadryl and received the cloth electrodes.The patient was later prescribed a z pack and steroids pill.

Manufacturer Narrative

A dhr review was completed with no noted nonconformances.There have been no alterations in raw materials used for production.Biocompatibility report states the skin contacting materials are non-cytotoxic, non-sensitizing and non-irritating.Samples were not returned for evaluation.No further investigation can be completed.

• 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: 17714292
• MDR Text Key: 323001826
• Report Number: 1317188-2023-00010
• 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: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• 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: 48322V13
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2023
• Date Report to Manufacturer: 09/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Female