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

Model Number	ES40030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rash (2033)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported the patient was red with a rash and was itchy beyond the electrode area.Directions for electrode prep were followed.The patient consulted a clinician and was prescribed (b)(6).
Additional Manufacturer Narrative
A review of the device history record was not performed during this investigation as a viable lot number was not received with the complaint.All device history records 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 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 placing the electrodes over already irritated skin.Biocompatibility testing is performed in accordance with iso(b)(4) and the (b)(6) was found to be non-cytotoxic, non-irritating and non-sensitizing.It is important to note that this test only provides confidence that (b)(6) 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; per the packaging instructions the electrodes wear time is 72 hours, 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.No corrective or preventative actions are necessary.However as part of continuous improvements a corrective and preventative action (capa) 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.
Additional Manufacturer Narrative
A review of the device history record was not performed during this investigation as a viable lot number was not received with the complaint.All device history records 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 repeated 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 in accordance with iso 10993-1 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, application to sensitive, irritated, or broken skin, using the electrodes for longer than intended based on packaging instructions; per the packaging instructions the electrodes wear time is <72 hours, 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.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.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): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• Manufacturer (Section G): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12989057
• Report Number: 1219103-2021-00341
• Device Sequence Number: 12153864
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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
• Device Model Number: ES40030
• Device Catalogue Number: ES40030
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female