BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INFANT HEEL WARMER PACKET

    MDR report key: 23437249 · Received October 31, 2025

    Report

    Report Number
    MW5178365
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    October 14, 2025
    Report Date
    October 24, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    MPO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFANT HEEL WARMER TURNED COLD INSTEAD OF HOT WHEN ACTIVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714070 MEDLINE INFANT HEEL WARMER PACKET INFANT HEEL WARMER (CHEMICAL HEAT PACK) MPO MEDLINE INDUSTRIES, LP - NORTHFIELD MDS138007 LOTVN25169A9

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown