BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN, INC.

    MDR report key: 23849496 · Received December 19, 2025

    Report

    Report Number
    2411236-2025-00003
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 19, 2025
    Manufacturer
    JIANGSU INTCO MEDICAL PRODUCTS CO., LTD.
    Product Code
    IMD
    UDI-DI
    00304040037119
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 40-YEAR-OLD FEMALE PATIENT WAS UNDERGOING CAPILLARY BLOOD COLLECTION WHEN A HOT PACK WAS APPLIED TO WARM THE SKIN. FOR THE FIRST 30 SECONDS, THE HOT PACK WAS PLACED DIRECTLY ON THE SKIN, AFTER WHICH A CLOTH WAS USED AS A BARRIER FOR THE REMAINING DURATION, TOTALING APPROXIMATELY TWO MINUTES OF APPLICATION. AS A RESULT, THE PATIENT SUSTAINED A SECOND-DEGREE BURN ON THE LEFT UPPER ARM AND A FIRST-DEGREE BURN ON THE RIGHT UPPER ARM, REQUIRING FIRST AID TREATMENT. THERE WAS NO LEAKAGE FROM THE PRODUCT ONTO THE PATIENT. THE BURNS HAVE SINCE HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244066 HENRY SCHEIN, INC. INSTANT SUMMER HOT 6X8.25 IMD JIANGSU INTCO MEDICAL PRODUCTS CO., LTD. 250426 00304040037119

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention