BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 317979 · Received February 23, 2001

    Report

    Report Number
    317979
    Event Type
    Injury
    Date Received
    February 23, 2001
    Date of Event
    February 18, 2001
    Report Date
    February 23, 2001
    Manufacturer
    *
    Product Code
    FNJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOME HEALTH AIDE VISTED PT TO PROVIDE BED BATH AND PERSONAL CARE. DURING THE BATH, SHE TURNED PT ONTO LEFT SIDE PT USED RIGHT HAND AND ARM TO HOLD ONTO SIDE-RAIL TO HOLD OVER ON LEFT SIDE. PT'S WEIGHT WAS RESTING ON RAIL WHEN SIDERAIL COLLASPED AND PT ROLLED OOB AND FELL ABOUT 3 FT ONTO FLOOR, LANDING ON BACK. 911 WAS CALLED. THE AMBULANCE CREW OF 4 MEN LIFTED PT OFF FLOOR TO CART. HOME HEALTH AIDE STAYED TO ASSIST PT UNTIL TAKEN BY AMBULANCE TO E.R.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7284 * SIDE RAIL FOR HOSPITAL BED FNJ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization 2. HOSPITAL BED,| 3. WHEELCHAIR.| 1. HOYER LIFT,