BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASCULAR UNKNOWN

    MDR report key: 4929844 · Received July 21, 2015

    Report

    Report Number
    3004526033-2015-00054
    Event Type
    Injury
    Date Received
    July 21, 2015
    Date of Event
    February 1, 2012
    Report Date
    June 24, 2015
    Manufacturer
    VIDACARE
    Product Code
    FMI
    PMA / PMN Number
    K141117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ARTICLE PUBLISHED BY THE SOCIETY OF CRITICAL CARE MEDICINE AND WOLTERS KLUWER HEALTH, INC WAS REVIEWED BY TELEFLEX. FOLLOW-UP WAS COMPLETED WITH THE PHYSICIAN WHO CONDUCTED THE STUDY. HE CONFIRMED THAT THE INTRAOSSEOUS DEVICE USED WAS THE ARROW EZ-IO. THERE WAS 1 CASE OF EXTRAVASATION AND SKIN NECROSIS. THERE IS NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472420 VASCULAR UNKNOWN EZ-IO INTRAOSSEOUS INFUSION SYSTEM FMI VIDACARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other