BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3019642 · Received March 17, 2013

    Report

    Report Number
    3019642
    Event Type
    Malfunction
    Date Received
    March 17, 2013
    Date of Event
    December 28, 2012
    Report Date
    March 11, 2013
    Manufacturer
    INVACARE CORPORATION
    Product Code
    KHY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CALLED STATING THE CANE COLLAPSED ON HER WHEN SHE WAS WALKING ON HER PORCH. THIS CAUSED THE PATIENT TO INJURE HER KNEE AND BREAK A COUPLE OF HER FALSE TEETH. PATIENT REQUESTED CALL BACK. MEDEQUIP WAS NOTIFIED OF SITUATION AND IS TRYING TO MAKE CONTACT WITH PATIENT FOR FOLLOW-UP. PATIENT'S CANE #40918 WAS RECALLED AND INVACARE MAILED A NEW CANE TO PATIENT'S HOME ADDRESS. IT IS UNKNOWN AT THIS TIME IF THE CANE WAS THE REPLACEMENT CANE THAT INVACARE SENT OR THE RECALLED CANE THAT WAS DISPENSED IN JUNE 2012. PATIENT ALSO RECEIVED AN HD CANE IN JUNE 2009.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CANE FOR WALKING STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111784 * CANE, SAFETY WALK KHY INVACARE CORPORATION 40918 *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR