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

Model Number	ES40030
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional 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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported they were previously using vermed electrodes when the skin irritation first started.Covidien soft-e electrodes were sent to the patient as an alternative for patients with sensitive skin.The patient is reporting red bumps and now they are oozing yellow pus.The patient has allergies to adhesives and consulted a doctor.No medical treatment was provided.The patient self treated with hydrocortisone cream and triamcinolone cream.
Additional 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.Because there was no lot number, a date of manufacture could not be determined.There were no samples received with this complaint therefore an examination of the reported issue 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.Biocompatibility testing is performed in accordance with iso 10993-1 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, or 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.However, a corrective and preventative action has been opened to review and investigate any potential for product causes.We will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: ELECTRODE H49P SOLID GEL
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 11027492
• Report Number: 1219103-2020-00309
• Device Sequence Number: 2692523
• Product Code: DRX
• UDI-Device Identifier: 20884527004796
• UDI-Public: 20884527004796
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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
• Operator of Device: No Information
• Device Model Number: ES40030
• Device Catalogue Number: ES40030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 02/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other