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 Problems Anaphylactic Shock (1703); Skin Burning Sensation (4540)

Event Date 11/22/2021

Event Type  Injury  

Event Description

Patient reported severe reaction to the gel from the patch.States patient baseline 11/2 patient was wearing the patch but then started having symptoms of anaphylactic shock.Patient was also experiencing shortness of breath, bruising and skin irritation with bleeding from the patch site.Patient consulted a clinician and was given steroids for medical treatment.Patient is improving.Biotel heart distributor provided additional information from their fda submission report.This is what they provided: she is currently feeling better but will be removing the device and sending back.She will consult with her doctor first before deciding to continue use of device.

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.A lot number could not be provided so a dhr review could not be conducted.Since the end customer (biotel heart distributor) reported the complaint, nissha medical technologies, the importer is also reporting the incident.

• 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: 15537159
• MDR Text Key: 301117347
• Report Number: 1317188-2022-00014
• 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: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• 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: 10/04/2022
• Distributor Facility Aware Date: 09/09/2022
• Date Report to Manufacturer: 10/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22 YR
• Patient Sex: Female