BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTICMED

    MDR report key: 21240313 · Received January 27, 2025

    Report

    Report Number
    21240313
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    December 27, 2024
    Report Date
    January 16, 2025
    Manufacturer
    ATLANTIC TRADING LLC
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    INFANT HEEL WARMER OUTER PLASTIC PUNCTURED AND FLUID LEAKING OUT WHEN ATTEMPTING TO ACTIVATE DISK WITHIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607182 ATLANTICMED PACK, HOT OR COLD, DISPOSABLE IMD ATLANTIC TRADING LLC C0012212-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown