BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 5643959 · Received May 10, 2016

    Report

    Report Number
    2411236-2016-00003
    Event Type
    Injury
    Date Received
    May 10, 2016
    Date of Event
    April 5, 2016
    Report Date
    April 14, 2016
    Manufacturer
    SHANGHAI INTCO MEDICAL SUPPLY CO., LTD.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT AFTER A FEW SECONDS AFTER PERFORMING CHEMOTHERAPY TREATMENT ON A MALE PATIENT FOR LYMPHOMA THE HOT PACK WAS HOT. THE NURSE THEN REMOVED THE HOT PACK FROM THE PATIENT'S LEFT ARM WHEN SHE NOTICED A BURN ON THE PATIENT'S ARM. THE BURN WAS TREATED WITH SILVADENE CREAM BY A NURSE PRACTITIONER IN THE OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299350 HENRY SCHEIN INSTANT SUMMER HOT IMD SHANGHAI INTCO MEDICAL SUPPLY CO., LTD. 012816

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other