MAUDE Adverse Event Report: COVIDIEN ELECTRODE H49P SOLID GEL; ELECTRODE, ELECTROCARDIOGRAPH

Model Number ES40030

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 10/09/2020

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 experienced severe redness, fluid discharge and raised bumps.The patient was previously wearing vermed electrodes when the skin irritation first started.The patient reported sensitive skin.The patient consulted a physician and was prescribed lotion and told to remove the electrodes for a week.

Manufacturer Narrative

A review of the device history record (dhr) was not performed during this investigation as a viable lot number was not received with the complaint.All dhrs are reviewed and approved by quality prior to release of product.There were no samples received with this complaint therefore an examination of the reported condition could not be made.Per the complaint report, no samples are expected.From a root cause analysis perspective, the cause of the skin irritation is most likely attributed to skin preparation, skin condition or specific skin sensitivities.It can also be caused by repeatedly placing electrodes in the same position or area which can irritate the skin, or by placing the electrodes over already irritated skin.Biocompatibility testing is performed in accordance with regulations and the gel was found to be non-cytotoxic, non-irritating and non-sensitizing.It is important to note that this test only provides confidence that 95% of the population will not have an adverse reaction.The use of this product requires an adherence to proper skin preparation protocols as documented on the product packaging.Improper application of the electrode is an application to sensitive, irritated, or broken skin, and using the electrodes for longer than intended based on packaging instructions.Applications without proper skin preparation may cause adhesion or skin irritation issues.The results of the manufacturing facility investigation were unable to confirm any potential root causes associated with the manufacture of product which would have contributed to the reported condition.No corrective or preventative actions are necessary.However, due to the number of complaints received specific to this issue a corrective and preventative action (capa) has been opened to review and investigate any potential for product causes.The manufacturing site will continue to trend this issue for future occurrences as part of the complaint review process.This complaint will be used for tracking and trending purposes.

• Brand Name: ELECTRODE H49P SOLID GEL
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 11636120
• MDR Text Key: 244481138
• Report Number: 1219103-2021-00320
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 20884527004796
• UDI-Public: 20884527004796
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: ES40030
• Device Catalogue Number: ES40030
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR