BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-IO

    MDR report key: 3792627 · Received April 14, 2014

    Report

    Report Number
    3004526033-2014-00004
    Event Type
    Injury
    Date Received
    April 14, 2014
    Report Date
    April 8, 2014
    Manufacturer
    VIDACARE CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K032885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING REPORT WAS RECEIVED FROM ONE OF OUR VASCULAR SALES SPECIALIST: I WAS SPEAKING WITH A PHYSICIAN FROM (B)(6). SHE HAD AN ADVERSE EVENT OCCUR WHILE USING THE EZ-IO. SHE WAS NOT SURE THE EXACT DATE. IT WAS A PEDIATRIC PATIENT (B)(6) OLD CARDIAC ARREST. THE IO WAS SUCCESSFULLY PLACED IN THE TIBIA AND RESUSCITATION DRUGS, FLUIDS, AND BLOOD WAS ADMINISTERED SUCCESSFULLY. HOWEVER, NECROSIS OCCUR FROM THE IO INSERTION DOWN THE EXTREMITY. THE EXTREMITY HAD TO BE AMPUTATED. THERE WAS A REPORTED CLOT IN THE VEIN OF THE UPPER LEG. VIDACARE HAS BEEN UNABLE TO ACQUIRE ANY ADDITIONAL INFORMATION FROM THE PHYSICIAN DESPITE REPEATED ATTEMPTS.

    Description of Event or Problem · 1

    ONE OF VIDACARE'S SALES SPECIALIST RECEIVED THE FOLLOWING INFORMATION FROM DR. (B)(6) A PHYSICIAN AT (B)(6). THE IO WAS SUCCESSFULLY PLACED IN THE TIBIA AND RESUSCITATION DRUGS, FLUIDS, AND BLOOD WERE ADMINISTERED SUCCESSFULLY DURING A CARDIAC ARREST OF A (B)(6) OLD. HOWEVER, NECROSIS OCCURED FROM THE IO INSERTION DOWN THE EXTREMITY. THE EXTREMITY HAD TO BE AMPUTATED. THERE WAS A REPORT CLOT IN THE VEIN OF THE UPPER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227743 EZ-IO INTRAOSSEOUS NEEDLE FMI VIDACARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Required Intervention| S