BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OOK SNOW

    MDR report key: 14406613 · Received May 16, 2022

    Report

    Report Number
    3009591865-2022-00011
    Event Type
    Injury
    Date Received
    May 16, 2022
    Date of Event
    April 27, 2022
    Report Date
    May 10, 2022
    Manufacturer
    UMANO MEDICAL INC.
    Product Code
    FNL
    UDI-DI
    00670482000104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    TECHNICAL SERVICE RECEIVED AN EMAIL FROM CUSTOMER REPORTING A PATIENT FALL WITH AN ORBITAL FRACTURE FOLLOWING AN ALLEGED UNDETECTED BED EXITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387334 OOK SNOW HOSPITAL BED FNL UMANO MEDICAL INC. 00670482000104

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other