BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    NEOLEAD RADIOLUCENT

    MDR report key: 16564823 · Received March 17, 2023

    Report

    Report Number
    16564823
    Event Type
    No answer provided
    Date Received
    March 17, 2023
    Date of Event
    March 8, 2023
    Report Date
    March 8, 2023
    Manufacturer
    NEOTECH PRODUCTS LLC
    Product Code
    DRX
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BLISTERS/SKIN INJURY FOUND UNDER EKG LEADS WHEN THEY WERE REMOVED FOR INFANTS BATH. MANUFACTURER RESPONSE FOR RADIOLUCENT NEOLEAD ECG ELECTRODES, RADIOLUCENT NEOLEAD ECG ELECTRODES. (PER SITE REPORTER)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754428 NEOLEAD RADIOLUCENT ELECTRODE, ELECTROCARDIOGRAPH DRX NEOTECH PRODUCTS LLC 2002-9035

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown