BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOLEAD RADIOLUCENT

    MDR report key: 16751002 · Received April 17, 2023

    Report

    Report Number
    16751002
    Event Type
    Malfunction
    Date Received
    April 17, 2023
    Date of Event
    March 24, 2023
    Report Date
    March 24, 2023
    Manufacturer
    NEOTECH PRODUCTS LLC
    Product Code
    DRX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LEADS REMOVED, GREEN LEAD ON PATIENT'S LEFT LOWER ABDOMEN LEFT BLISTERY MARK. MANUFACTURER RESPONSE FOR RADIOLUCENT NEOLEAD ECH ELECTRODES, NEOTECH PRODUCTS LLC (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2259110 NEOLEAD RADIOLUCENT ELECTRODE, ELECTROCARDIOGRAPH DRX NEOTECH PRODUCTS LLC 2022-9052

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other