BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVACARE CORPORATION

    MDR report key: 609395 · Received May 9, 2005

    Report

    Report Number
    609395
    Event Type
    Malfunction
    Date Received
    May 9, 2005
    Date of Event
    April 7, 2005
    Report Date
    May 9, 2005
    Manufacturer
    INVACARE CORPORATION
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS SEEN IN EMERGENCY DEPARTMENT EARLIER IN THE DAY AND WAS SENT HOME WITH A NEW FOLDING ADULT WALKER. THE PATIENT WAS USING WALKER AT HOME LATER IN THE DAY WHEN ONE OF THE WALKER LEGS SNAPPED OFF CAUSING THE PATIENT TO FALL TO GROUND. THE PATIENT WAS UNABLE TO GET UP AND REQUIRED ASSISTANCE. NO INJURIES WERE NOTED. THE FAMILY RETURNED THE BROKEN WALKER TO THE EMERGENCY DEPARTMENT AND RECEIVED A REPLACEMENT. THE VENDOR, APRIA, WAS NOTIFIED OF THE OCCURRENCE. THE LEG THAT SNAPPED WAS THE RIGHT FRONT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE CORPORATION WALKER FOLDING JR DUAL RELIEF ITJ INVACARE CORPORATION 6291-JR 40701
    2 DUAL RELEASE PADDLE JUNIOR WALKER WALKER ITJ APRIA HEALTHCARE GROUP INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR