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

Model Number	31.1355821
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	07/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.Photos were provided of a newborn or neonate and the reported issue was observed on the patient.However, there were no physical samples returned for evaluation, therefore the affected device could not be evaluated.As such, a root cause could not be determined.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
The customer reported that during a wash/bath, when changing the devices, the nurse observed 2 burns under two electrodes of 2 cm in diameter.These burns are associated with the gel present in the composition of the electrode since the surface burnt skin is identical to the gel contained in the electrodes.One blister has the presence of purulent fluid and the other blister has ruptured.The skin underneath has an erythema.There were no creams or any other product on the baby's skin.Treatment involved burn care with prescription and adjustment of analgesic treatment.The child had been experiencing pain for several hours, assessed under evendol3 0 6/15 despite continuous administration of morphine and administration of level 1 analgesic.Failure of healing, risk of infection.

• 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: 22865596
• Report Number: 1423537-2025-00340
• Device Sequence Number: 7733063
• Product Code: DRX
• UDI-Device Identifier: 20192253016885
• UDI-Public: (01)20192253016885
• 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
• Report Date (Section B): 08/21/2025

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: 31.1355821
• Device Catalogue Number: 31.1355821
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 08/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown