MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KENDALL; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	31.1245.21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696); Blister (4537)
Date of Event	12/20/2024
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 skin burn in young patients.Additional information received on (b)(6)2025 stated that the burning phenomenon is recent and affected 4 children.Burns are variable (blister with deeper burns) and are more likely to be between the 2nd and 3rd degree.Some children had to receive treatment for burns.This case is for patient 1.
Event or Problem Description
The customer reported skin burns in young patients.Additional information received on 06jan2025 stated that the burning phenomenon is recent and affected 4 children.Burns are variable (blister with deeper burns) and are more likely to be between the 2nd and 3rd degree.Some children had to receive treatment for burns.This case is for patient 1.Additional information received on 20jan2025 from the pharmacist stated that the electrodes are no longer in question.The problem comes from the machine used and not from the electrodes.
Additional Manufacturer Narrative
Additional information received on 20jan2025 was added to section b5.
Additional Manufacturer Narrative
The device history record (dhr) for lot 24249c was reviewed and no anomalies related to the reported issue were observed.There were no samples returned for evaluation and the customer stated that the reported event was not due to the cardinal health electrodes, but instead caused by the machine that was used.We will continue to monitor related reports to determine if actions are necessary.

• Brand Name: KENDALL
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; quedlinburger strasse 39a; halberstadt D3882 0; GM D38820
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21184385
• Report Number: 1423537-2025-00039
• Device Sequence Number: 19889717
• Product Code: DRX
• UDI-Device Identifier: 20192253016854
• UDI-Public: (01)20192253016854(10)24249C
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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): 02/19/2025

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: 31.1245.21
• Device Catalogue Number: 31.1245.21
• Device Lot Number: 24249C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 01/21/2025; 02/19/2025
• 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