BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANDMARK MIDLINE

    MDR report key: 41842 · Received September 19, 1996

    Report

    Report Number
    41842
    Event Type
    Injury
    Date Received
    September 19, 1996
    Date of Event
    September 5, 1996
    Report Date
    September 17, 1996
    Manufacturer
    MENLO CARE, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A MIDLINE CATHETER WAS INSERTED IN THE LEFT MID-FOREARM PER PROCEDURE WITHOUT DIFFICULTY. THE PT IMMEDIATELY EXPERIENCED A SEVERE REACTION COMPLAINING OF NAUSEA, HEADACHE, NUMBNESS OF FACE, SEVERE SHOULDER TO BACK PAIN, SHORTNESS OF BREATH AND DIZZINESS. BLOOD PRESSURE AT 240/120. THE CATHETER WAS REMOVED AND ALL SYMPTOMS SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARK MIDLINE CATHETER FOZ MENLO CARE, INC. * 511061M

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R