BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKER, RIGID, NON FOLDING

    MDR report key: 836895 · Received February 19, 2007

    Report

    Report Number
    1417592-2007-00010
    Event Type
    Malfunction
    Date Received
    February 19, 2007
    Date of Event
    January 26, 2007
    Report Date
    January 26, 2007
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NXE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WALKER WAS RECEIVED WITH GUARDIAN WHEEL EXTENSIONS ON THE FRONT LEGS, AND AN UNIDENTIFIED MANUFACTURER'S EXTENSIONS ON THE BACK LEGS. THE WALKER HAS A BROKEN RIGHT REAR LEG AT THE RIVET WHICH JOINS THE CROSS FRAME AND THE REAR LEG. THE HARDNESS AND THICKNESS OF THE BROKEN LEG BOTH MEASURED WITHIN PRODUCT SPECIFICATION. THE STABILITY OF THE WALKER AS RECEIVED WITH THE NON-MEDLINE FRONT AND REAR LEG EXTENSIONS WAS EVALUATED. THE BROKEN RIGHT REAR LEG WAS PUT BACK INTO PLACE IN A VERTICAL POSITION. THE DIAGONAL MEASUREMENT BETWEEN THE LEFT REAR LEG AND RIGHT FRONT LEG IS 28.5 INCHES. THE DIAGONAL MEASUREMENT BETWEEN THE RIGHT REAR LEG AND LEFT FRONT LEG IS 27 INCHES. WHEN MEASURING THE SAME DIAGONAL LENGTH WITH THIS STYLE OF WALKER AND SIMILAR MEDLINE EXTENSIONS, THE LEGS ARE EQUALLY SPACED AT 28.75 INCHES. IT IS CRITICAL FOR THE WALKER TO HAVE AN APPROXIMATELY SQUARE TEMPLATE TO BE STABLE. IF THIS SQUARE IS NOT EQUALLY SPACED, FORCE IS NOT APPLIED/DISPERSED EVENLY ACROSS THE FOUR LEGS OF THE WALKER. THE INSTRUCTION BOOKLET THAT SHIPS WITH THE WALKER HAS AN "IMPORTANT PRECAUTIONS" AREA WHICH INCLUDES THE FOLLOWING STATEMENT: "USE MEDLINE ACCESSORIES ONLY. USE OF OTHER ACCESSORIES MAY RESULT IN IMPROPER FIT AND RISK OF FALL AND INJURY." THE REASON FOR THE PRECAUTION IS THAT MEDLINE WALKERS HAVE HAD EXTENSIVE TESTING WITH MEDLINE ACCESSORIES TO ENSURE THAT THE SQUARE TEMPLATE, AND THUS WALKER STABILITY, IS MAINTAINED WHEN ACCESSORIES ARE APPLIED TO THE WALKER. THIS ENSURES AN EVEN DISTRIBUTION OF FORCE APPLIED TO ALL FOR LEGS WHEN THE WALKER IS USED APPROPRIATELY. ADDITIONALLY, THE GUARDIAN LABEL ON THE FRONT LEG EXTENSIONS STATES: "USE ONLY ON GUARDIAN WALKERS." FOR ADDITIONAL EVALUATION, A WALKER SAMPLE WAS RANDOMLY SELECTED FROM INVENTORY FOR COMPARISON AND STATIC LOADING TESTING. THE SAMPLE WAS TESTED AT AN INCLINATION OF 18 DEGREES WITH A VERTICAL FORCE APPLIED ON THE TWO HAND GRIPS. THE UNIT SUSTAINED 1765 LBS OF FORCE WITHOUT ANY DEFORMATION.

    Description of Event or Problem · 1

    REPORT RECEIVED THAT WHILE THE WALKER WAS BEING USED BY A PATIENT, IT BROKE AT THE CROSS BRACE ATTACHED TO THE RIGHT REAR LEG AT THE BOLT AREA. THE PATIENT FELL AND RECEIVED SEVERAL SKIN TEARS TO HER ARMS. NO OTHER INJURY WAS REPORTED. THE REPORT SOURCE STATES THE WALKER WAS PROVIDED TO THE PATIENT THE DAY BEFORE THE EVENT. SHE HAD BEEN INSTRUCTED IN PROPER USE BY A PHYSICAL THERAPIST. THE WALKER HAD FRONT WHEEL AND REAR GLIDER EXTENSIONS APPLIED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALKER, RIGID, NON FOLDING WALKER NXE MEDLINE INDUSTRIES, INC. MDS86204 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR WALKER WHEEL AND REAR LEG EXTENSIONS MFG BY| GUARDIAN.