BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL POSITIONING DEVICE

    MDR report key: 8767646 · Received July 8, 2019

    Report

    Report Number
    3007278668-2019-00001
    Event Type
    Injury
    Date Received
    July 8, 2019
    Date of Event
    September 20, 2018
    Report Date
    July 1, 2019
    Manufacturer
    PIVOTAL HEALTH SOLUTIONS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ELDERY PATIENT WAS BEING ADJUSTED INTO POSITION ON THE EPD WHEN HIS LEGS RECOILED AND HIS FOOT HIT THE BOTTOM ON THE FOOTPLATE AND WAS CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562261 EPIDURAL POSITIONING DEVICE EPD FWZ PIVOTAL HEALTH SOLUTIONS EPD

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Other