MAUDE Adverse Event Report: CARDINAL HEALTH 31.1925.21 H92SG ECGELPRSTFOAM57X34MMX50; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	31.1925.21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	10/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the patient had a long-range electrocardiogram for heart disease, and the skin covered by the electrodes became red with skin lesions, so the electrodes were stopped, and erythromycin ointment was applied to the skin.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured in january 2022.A physical sample or a picture was not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.It should be noted that skin irritations were caused by an allergic reaction against one or more components of the electrode, pre-treated skin or medication of the patient that leads to allergic reactions.At this time, a corrective and preventive action is not deemed necessary.This complaint will be recorded for tracking and trending purposes.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.
Event or Problem Description
The customer reported that the patient had a long-range electrocardiogram for heart disease, and the skin covered by the electrodes became red with skin lesions, so the electrodes were stopped, and erythromycin ointment was applied to the skin.Additional information was received and stated that the electrode was placed on to the patient's skin for 8 hours.The skin lesion was not painful to touch.The ecg electrodes were not moved to different areas of the skin due to the redness with skin lesions.Per customer, 1 ml of erythromycin ointment was applied to the patient's skin.There was no follow up testing or medical intervention required for the patient involved.

• Brand Name: 31.1925.21 H92SG ECGELPRSTFOAM57X34MMX50
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; quedlinburger strasse 39a; halberstadt D3882 0; GM D38820
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16134910
• Report Number: 9710060-2023-00211
• Device Sequence Number: 17809747
• Product Code: DRX
• UDI-Device Identifier: 20192253016984
• UDI-Public: 20192253016984
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2023

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: 31.1925.21
• Device Catalogue Number: 31.1925.21
• Device Lot Number: 22010C
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 01/05/2023; 01/05/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 01/17/2023; 02/22/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown