BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OOK SNOW

    MDR report key: 11857970 · Received May 20, 2021

    Report

    Report Number
    3009591865-2021-00011
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 20, 2021
    Manufacturer
    UMANO MEDICAL INC
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    505

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER WAS CONTACTED BY THE DISTRIBUTOR REPORTING AN OUT OF THE BOX FAILURE TO THE RIGHT FOOT END SIDE RAIL OF A MEDICAL BED. A FIXTURE OF THE SIDERAIL ARM WAS FOUND DEFECTIVE ON DELIVERY. NO PATIENT INVOLVEMENT, DEVICE WAS NOT PUT IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754347 OOK SNOW MEDICAL BED FNL UMANO MEDICAL INC FL36

    Patients

    Seq Age Sex Outcome Treatment
    1