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

Model Number ES40030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Skin Infection (4544)

Event Date 11/30/2020

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's skin was itchy and had bumps that burst with yellow discharge coming out in the entire electrode area after the use of three electrodes.The patient was previously using vermed electrodes but was sent soft-e electrodes as a replacement for the patient to continue enrollment.The patient did not report having sensitive skin or allergies.The instructions for electrode prep were followed.The patient did not consult a clinician, self-treat, or self-medicate.There is no further information available.

Manufacturer Narrative

Additional information: the device history records (dhrs) were reviewed for the reported lot number.There were notes about issues, however these types of issues most likely would not cause issues as stated in the complaint report.The dhr reviews show that all acceptance criteria inspections were within acceptable limits during the production process.There were no samples received with this complaint, therefore an examination of the reported issue could not be made.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.The issue can also be caused by repeatedly placing electrodes in the same position or area which can irritate the skin.Or placing the electrodes over already irritated skin.Biocompatibility testing is performed and 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, application to sensitive, irritated or broken skin, using the electrodes for longer than intended based on packaging instructions may cause adhesion or skin irritation issues.A risk assessment was performed including a review of the pfmea which indicates skin irritation could be a result of low ph in the gel mix.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.

• Brand Name: ELECTRODE H49P SOLID GEL
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 11178524
• MDR Text Key: 227063571
• Report Number: 1219103-2021-00312
• 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: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• 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
• Device Lot Number: 026536X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8 YR