BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OOK SNOW

    MDR report key: 8148109 · Received December 10, 2018

    Report

    Report Number
    3009591865-2018-00021
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    November 13, 2018
    Report Date
    December 10, 2018
    Manufacturer
    UMANO MEDICAL INC
    Product Code
    FLN
    UDI-DI
    00670482000104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER CONTACTED SERVICE SUPPORT FOR AN INTEGRATED BED EXIT DETECTION SYSTEM ALLEGEDLY NOT WORKING PROPERLY. PATIENT "FELT" WITH SCRATCH ON THE SCALP; NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985759 OOK SNOW MEDICAL BED FLN UMANO MEDICAL INC FL36 00670482000104

    Patients

    Seq Age Sex Outcome Treatment
    1 Other