BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-IO

    MDR report key: 3848416 · Received April 18, 2014

    Report

    Report Number
    3004526033-2014-00005
    Event Type
    Injury
    Date Received
    April 18, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 16, 2014
    Manufacturer
    VIDACARE
    Product Code
    FMI
    PMA / PMN Number
    K032885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6), REPORTED THE FOLLOWING INFO TO TELEFLEX MEDICAL SALES SPECIALIST: FEMALE PT, DOB: (B)(6) 1992, INTOXICATED AND BELLIGERENT RECEIVED AN EZ-IO IN THE PROXIMAL TIBIA. EXTRAVASATION OCCURRED FOLLOWED BY A FASCIOTOMY. THE PT'S LIMB WAS SAVED.

    Description of Event or Problem · 1

    PT PRESENTED TO ER UNDER THE INFLUENCE OF DRUGS AND ALCOHOL. IO WAS INSERTED INTO PT'S TIBIA AND INFUSED FOR FIRST HOUR. DURING HOUR TWO THE ATTENDING NURSE NOTED THAT THE PT'S CALF WAS SWOLLEN AND COLD AND THAT THE PT COULD NOT FLEX HER FOOT. THE IO WAS REMOVED AND AN ORTHOPEDIC SURGEON WAS CONSULTED. AN EMERGENCY FASCIOTOMY WAS PERFORMED AND ALL FUNCTION AND CIRCULATION WAS RESTORED. SHE HAD TWO ADDITIONAL WOUND IRRIGATION ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238785 EZ-IO INTRAOSSEOUS NEEDLE SET FMI VIDACARE 25MM NEEDLE SET

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| R