MAUDE Adverse Event Report: COVIDIEN ELECTRODE ECL 530 MEDITRACE FM; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 31013926

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Skin Irritation (2076)

Event Date 09/20/2019

Event Type  Injury  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the patient was using the electrodes for 24 hour holter monitoring.The patient had itching and some burning while the electrodes were on.The electrodes were challenging to remove and there was redness on the skin which worsened the next day to a severe skin reaction.The patient contacted her doctor and was prescribed hyderm (1%) topical cream as well as mupirocin 2% topical cream.The patient has not had any skin issues in the past.

Manufacturer Narrative

Additional information the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Because no sample was returned with this complaint, no product examination was possible.The complaint will be reopened if a sample is received at a later date.Photos were provided by the customer.Review of the first and second photos showed one pouch, confirming the lot and product code is the same as the lot and product code submitted with the complaint.Review of the last three photos confirmed the reported issue of skin irritation.These electrodes are one time use and can be used for up to 72 hours at which point should be replaced by a new electrode.Based on the information provided in the complaint, a root cause could not be established.This product family has been tested according to guidelines for biocompatibility that found both the hydrogel and skin contacting foam adhesive to be non-cytotoxic, non-irritating, and non-sensitizing.There have been no design changes to this product within the past year that would contribute to any increased probability for skin irritation on patients.Although this complaint is confirmed, there is no evidence that there was anything wrong in the manufacturing of the device.No complaint trend exists; therefore, corrective and preventative action will be limited to tracking and trending analysis.

• Brand Name: ELECTRODE ECL 530 MEDITRACE FM
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• MDR Report Key: 9250757
• MDR Text Key: 179401332
• Report Number: 9681860-2019-00507
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 30884527005875
• UDI-Public: 30884527005875
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 31013926
• Device Catalogue Number: 31013926
• Device Lot Number: 907449X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other