BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OOK SNOW

    MDR report key: 12052850 · Received June 23, 2021

    Report

    Report Number
    3009591865-2021-00016
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    May 28, 2021
    Report Date
    June 23, 2021
    Manufacturer
    UMANO MEDICAL INC
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER THAT AN INTEGRATED BED EXITING DETECTION SYSTEM DID NOT FUNCTION. THERE WAS NO FALL, NO INJURY ASSOCIATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949810 OOK SNOW HOSPITAL BED FNL UMANO MEDICAL INC FL36

    Patients

    Seq Age Sex Outcome Treatment
    1 Other