BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OOK SNOW

    MDR report key: 6994766 · Received November 1, 2017

    Report

    Report Number
    3009591865-2017-00002
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Report Date
    November 1, 2017
    Manufacturer
    UMANO MEDICAL INC
    Product Code
    FNL
    UDI-DI
    00670482000067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS ALLEGED BY A USER THAT 3 PATIENT FALL TOOK PLACE, IN THE WEEKS BEFORE THE ALLEGATION, WHILE USING THE OOK SNOW MEDICAL BED. ONE OF THE FALL MAY HAVE RESULTED IN A FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772691 OOK SNOW MEDICAL BED FNL UMANO MEDICAL INC OOK SNOW 00670482000067

    Patients

    Seq Age Sex Outcome Treatment
    1 Other