BEUDAMED
    FDA Adverse Event Death Summary report: N

    BED CANE

    MDR report key: 1404765 · Received June 17, 2009

    Report

    Report Number
    MW5011598
    Event Type
    Death
    Date Received
    June 17, 2009
    Date of Event
    April 18, 2007
    Report Date
    June 17, 2009
    Manufacturer
    STANDERS, INC
    Product Code
    IKX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DECEASED WAS ASPHYXIATED AND FOUND ENTRAPPED BETWEEN THE BED CANE, BED RAIL AND MATTRESS. THE COMPANY APPEARS TO BE A MEDICAL DEVICE COMPANY WITH MULTIPLE PRODUCTS ON THE MARKET. THEY DO NOT APPEAR TO BE REGISTERED WITH THE FDA. THE MARKETING MATERIALS SHOW A MUCH BROADER USE THAN WHAT IS SHOWN IN THE INSTRUCTIONS. THE PRODUCT HAS MULTIPLE SAFETY ISSUES AND IS UNSTABLE. THE MISLEADING MARKETING INCREASES THE RISKS AND MISUSE LEADING THE USER TO THINK THEY MISUSED THE DEVICE. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: NONE INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BED CANE BED CANE BED RAIL IKX STANDERS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death