BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL

    MDR report key: 18685010 · Received February 12, 2024

    Report

    Report Number
    18685010
    Event Type
    Malfunction
    Date Received
    February 12, 2024
    Date of Event
    December 23, 2023
    Report Date
    December 27, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: PATIENT FOUND WITH SMALL OPEN LESION ON UPPER CHEST AFTER REMOVAL OF ELECTROCARDIOGRAM (ECG) LEADS. BACKGROUND: PATIENT TRANSFERRED FROM NEONATE INTENSIVE CARE UNIT (NICU) TO ICN. THIS REGISTERED NURSE (RN) REMOVED ECG LEADS TO GIVE PATIENT A BATH. ADHESIVE REMOVER WAS USED TO REMOVE LEADS. ON RIGHT UPPER CHEST, OPEN LESION/WOUND WAS FOUND. ASSESSMENT: LESION RESEMBLES BURN MARK FROM ECG ELECTRODE. THIS RN NOTIFIED NNP (NEONATAL NURSE PRACTITIONER) AND ASKED IF NNP WANTED TO ORDER A SWAB FOR LESION. NNP DECLINED ORDERING SWAB FOR LESION, AS PATIENT DOES NOT HAVE ANY OTHER SIGNS OR SYMPTOMS OF INFECTION. RECOMMENDATION: EVALUATE IF OTHER PATIENTS ARE EXPERIENCING SIMILAR MARKS FROM ECG LEADS. RN WILL REQUEST WOUND CARE CONSULT. ASSESSED PATIENT DAYS AFTER, SCAB SEEN ON INFANT'S CHEST. LEADS WERE REMOVED WITH ADHESIVE REMOVAL, DIFFICULT TO DETERMINE CAUSE OF SCABBING. WOUND CONSULT WAS PLACED, ADVISED TO PLACE AQUAPHOR ON INFANT'S SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297846 KENDALL ELECTRODE, ELECTROCARDIOGRAPH DRX CARDINAL HEALTH 31424785 328210X

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA Male