BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OOK SNOW

    MDR report key: 6959511 · Received October 18, 2017

    Report

    Report Number
    3009591865-2017-00001
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    September 20, 2017
    Report Date
    October 17, 2017
    Manufacturer
    UMANO MEDICAL INC
    Product Code
    FNL
    UDI-DI
    00670482000067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS BEING RESTRAINT IN BED WITH HEAD AND FOOT SIDERAILS RAISED UP, THAT THE PATIENT WAS ABLE TO GET OUT OF THE BED THROUGH A SPACE AT THE FOOT END OF THE BED, THAT PATIENT TOOK A WALKER, WALKED AND FELL. IT WAS REPORTED THAT THE STAFF WAS NOT USING THE BED EXIT MONITORING SYSTEM AS THE SIDERAILS ARE SEEN AND USED AS RESTRAINT IN THEIR PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739555 OOK SNOW MEDICAL BED FNL UMANO MEDICAL INC OOK SNOW 00670482000067

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O