BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OOK SNOW

    MDR report key: 11785752 · Received May 6, 2021

    Report

    Report Number
    3009591865-2021-00006
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    March 28, 2021
    Report Date
    May 6, 2021
    Manufacturer
    UMANO MEDICAL INC
    Product Code
    FNL
    Removal / Correction Number
    RES 85592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER WAS CONTACTED BY USER SITE FOR REPORTING OF A PATIENT FALL FOLLOWING AN ALLEGED UNDETECTED BED EXITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682555 OOK SNOW MEDICAL BED FNL UMANO MEDICAL INC FL36

    Patients

    Seq Age Sex Outcome Treatment
    1 Other