BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 21804818 · Received April 9, 2025

    Report

    Report Number
    21804818
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    February 28, 2025
    Report Date
    April 3, 2025
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IMD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    INSTANT HOT PACK 6X6IN UPPER SEAL LEAKING. GEL GOT ON PATIENT'S ABDOMEN. NO REACTION NOTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471330 MEDLINE PACK, HOT OR COLD, DISPOSABLE IMD MEDLINE INDUSTRIES, INC. MDS139008 HCN24251-90

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female