BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANDMARK MIDLINE CATHETER

    MDR report key: 33902 · Received July 3, 1996

    Report

    Report Number
    MW1009435
    Event Type
    Injury
    Date Received
    July 3, 1996
    Date of Event
    June 12, 1996
    Report Date
    July 2, 1996
    Manufacturer
    MENLO CARE, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ONE MONTH AGO A PHYSICIAN WAS PLACING THE CATHETER. HIS PT DEVELOPED HYPERTENSION, SHORTNESS OF BREATH, DIAPHORESIS, CHEST PAIN, HIVES, AND TONGUE SWELLING. PHYSICIAN WAS READING AN ARTICLE ON 7/1/96 WHICH WAS PUBLISHED IN THE FDA MEDICAL BULLETIN AND REALIZED THAT HIS PT HAD THE SAME SYMPTOMS THAT WERE ADDRESSED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARK MIDLINE CATHETER MIDLINE CATHETER FOZ MENLO CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization