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 Blister (4537)

Event Date 02/17/2022

Event Type  Injury  

Event Description

Patient communication of consulting a healthcare professional stating that there was blistering, tearing, and itchinig of the skin from the device electrodes.The physician prescribed a steroid cream.5% to apply to the affected area.The patient was offered alternative sensitive skin electrodes for monitoring period completion.

Manufacturer Narrative

Medico was emailed for their biocompatibility report.The results of the gel and adhesive (those which have direct contact with skin) were both found to be non-cytotoxic, non-sensitizing, and non-irritating.Medico also states they used approved suppliers that follow standardized qms and all raw materials are inspected when received in.Medico has stated that after review of their raw material and production records, there were no changes to the composition of the raw materials and no changes in production.A trend report shows there has not been a significant increase in skin reaction complaints over the past 3 years and the electrodes are sold worldwide.The ifu (on the pouch) states the electrodes are hypoallergenic and an electrode is only to be worn for less than 72 hours.As a lot number was not provided, a review of lot record paperwork cannot 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 20130 5; IN 201305
• MDR Report Key: 14112346
• MDR Text Key: 289274035
• Report Number: 1317188-2022-00008
• 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: 04/14/2022,03/14/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2022
• Distributor Facility Aware Date: 03/15/2022
• Event Location: Other
• Date Report to Manufacturer: 04/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female