BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE INFANT HEEL WARMER

    MDR report key: 16411814 · Received February 17, 2023

    Report

    Report Number
    MW5115080
    Event Type
    Injury
    Date Received
    February 17, 2023
    Date of Event
    February 2, 2023
    Report Date
    February 16, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    MPO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRIMARY RN WAS COLLECTING A POC (POINT-OF-CARE) GLUCOSE ON AN INFANT WHEN SHE ATTEMPTED TO USE A MEDLINE INFANT HEEL WARMER BY BREAKING THE INNER COMPONENT TO START THE WARMING. HOWEVER, THE HEEL WARMER SPLIT THROUGH THE OUTSIDE BAG, SPILLING WARM GEL OUT. IT DID NOT EVER TOUCH THE INFANT. DEFECTIVE WARMER WAS SET ASIDE IN A PLASTIC BAG KEPT AT THE NURSES' STATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611855 MEDLINE INFANT HEEL WARMER INFANT HEEL WARMER (CHEMICAL HEAT PACK) MPO MEDLINE INDUSTRIES, LP - NORTHFIELD MDS138007 UN22199A18

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Male Required Intervention