BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAREX DESIGNER OFFSET CANE - BLUE

    MDR report key: 6297006 · Received February 2, 2017

    Report

    Report Number
    3012316249-2017-00011
    Event Type
    Injury
    Date Received
    February 2, 2017
    Date of Event
    November 10, 2016
    Report Date
    October 6, 2020
    Manufacturer
    UNKNOWN
    Product Code
    KHY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED FOR INSPECTION. UPON INSPECTION, THE ITEM WAS FOUND TO HAVE BEEN OPENED AND USED. THE CUSTOMER STATED THAT THE STRAP BROKE ON THE CANE CAUSING HER TO FALL AND GET HURT. THE STRAP IS CONNECTED TO A PLASTIC SLEEVE THAT IS THEN SECURED INTO THE FRAME OF THE CANE. THE PLASTIC SLEEVE APPEARS TO BE LOCKED INTO PLACE WITH GLUE. THE GLUE APPEARS TO HAVE COME UNDONE, RESULTING IN THE PLASTIC SLEEVE AND STRAP DETACHING FROM THE UNIT.

    Description of Event or Problem · 1

    THIS CUSTOMER HAD EXPERIENCED A PROBLEM WITH THE BLUE OFFSET CANE. THIS CUSTOMER/END-USER CLAIMS THAT THE STRAP BROKE ON THE CANE, CAUSING HER TO FALL AND GET HURT. THE EVENT HAD OCCURRED IN THE END-USER'S HOME, ON LAMINATE FLOORING, COMING INTO HER HOUSE VIA ENTRYWAY. THE END-USER WAS ALREADY GOING TO THE ORTHOPEDIC DOCTOR FOR HER FOOT, AND WAS UNABLE TO USE CRUTCHES, SO SHE WAS INSTRUCTED TO USE A CANE. SHE PUT THE STRAP ON HER WRIST, AND REACHED OUT TO PUT HER HAND ON THE HANDLE AND THE STRAP BROKE, CAUSING HER TO FALL ON HER RIGHT SHOULDER. SHE DIDN'T REALIZE HER SHOULDER WAS HURT UNTIL A FEW DAYS LATER. SHE WENT BACK TO OUR CUSTOMER USING ONE OF THEIR ELECTRIC CHAIRS, AND SHOWED THE REP THAT THE STRAP BROKE AND SHE FELL. THE REP (FROM OUR CUSTOMER) PROVIDED HER WITH A NEW CANE AND TOOK THE BROKEN ONE. SHE WENT TO THE ORTHOPEDIC DOCTOR TO FOLLOW UP ON HER FOOT, AND SHE TOLD THE DOCTOR HER SHOULDER WAS HURTING. THE DOCTOR PRESCRIBED MEDICINE FIRST, AND THAT DIDN'T WORK, SO THEN THE DOCTOR GAVE HER A CORTISONE SHOT. SHE IS STILL NOT FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80089 CAREX DESIGNER OFFSET CANE - BLUE CANE KHY UNKNOWN FGA51500 BLUE UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other