BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BED, TOTALCARE GC

    MDR report key: 1251823 · Received November 22, 2008

    Report

    Report Number
    1251823
    Event Type
    Malfunction
    Date Received
    November 22, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 22, 2008
    Manufacturer
    HILL-ROM COMPANY, INC.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT TRYING TO GET UP TO USE BEDSIDE COMMODE, PATIENT USED BED RAILING TO ASSIST HERSELF IN GETTING OUT OF BED, BUT BED RAIL WAS NOT SECURED AND PATIENT FELL TOWARD THE COMMODE CAUSING SMALL CUT BEHIND RIGHT EAR. PATIENT STATED SHE WAS NOT GOING TO SAY ANYTHING UNTIL SHE DISCOVERED A SMALL AMOUNT OF BLOOD TRICKLE DOWN HER NECK. BLEEDING STOPPED WITH APPLICATION OF CLOTH. M.D. NOTIFIED. PATIENT DID NOT COMPLAIN OF OTHER INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED, TOTALCARE GC BED, HOSPITAL FNL HILL-ROM COMPANY, INC. TOTAL CARE GC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR