BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTICMED INFANT HEEL WARMER

    MDR report key: 24230952 · Received February 2, 2026

    Report

    Report Number
    24230952
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    August 2, 2025
    Report Date
    January 20, 2026
    Manufacturer
    ATLANTIC TRADING LLC
    Product Code
    MPO
    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

    HEEL WARMER ALREADY ACTIVATED IN SUPPLY BIN. NEXT HEEL WARMER I GRABBED, LEAKED ALL OVER PATIENT AFTER BEING ACTIVATED. I AM CONSTANTLY HAVING ISSUES WITH THIS BRAND.NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290844 ATLANTICMED INFANT HEEL WARMER INFANT HEEL WARMER (CHEMICAL HEAT PACK) MPO ATLANTIC TRADING LLC C0012212-1

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Unknown