BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANDMARK MIDLINE VENOUS ACCESS DEVICE

    MDR report key: 42523 · Received October 11, 1996

    Report

    Report Number
    1618732-1996-00049
    Event Type
    Injury
    Date Received
    October 11, 1996
    Date of Event
    September 5, 1996
    Report Date
    September 17, 1996
    Manufacturer
    MENLO CARE, INC.
    Product Code
    FOZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CATHETER WAS INSERTED IN THE LEFT MID-FOREARM PER PROCEDURE WITHOUT DIFFICULTY. THE PT IMMEDIATELY EXPERIENCED A SEVERE REACTION COMPLAINING OF NAUSEA, HEADACHE, NUMBENESS 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 VENOUS ACCESS DEVICE PERIPHERALLY INSERTED MIDLINE CATHETER FOZ MENLO CARE, INC. NA 511061M

    Patients

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