BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DMI® TWO-BUTTON RELEASE FOLDING WALKER

    MDR report key: 8278922 · Received January 25, 2019

    Report

    Report Number
    1422443-2019-00001
    Event Type
    Injury
    Date Received
    January 25, 2019
    Date of Event
    November 30, 2018
    Report Date
    January 25, 2019
    Manufacturer
    VALENTINE INTERNATIONAL LIMITED
    Product Code
    ITJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY PROVIDED THREE PHOTOS OF THE UNIT. BASED UPON THESE, WE ARE UNABLE TO DETERMINE WHAT HAPPENED OR MAKE ANY CONCLUSIONS. THE FACILITY WILL NOT RELEASE THE UNIT AND HAS NOT SUPPLIED ADDITIONAL PHOTOS FOR OUR EVALUATION. DUE TO THIS REPORT, SEVERAL UNITS FROM OUR CURRENT INVENTORY OF THE SAME MODEL (802-1044-0100) AND A SIMILAR MODEL (500-1045-0100) WERE TESTED IN A MANNER TO ATTEMPT TO SIMULATE CONDITIONS THAT WOULD RESULT IN HAVING THE WALKER BREAK OR COME APART. IN "ADDITON", ALL PIECES OF THE FRAME TUBING, SCREWS, RIVETS AND WELDS WERE EXAMINED FOR DAMAGE AND PROPER ASSEMBLY. THE TESTING AND EXAMINATION FOUND NO ISSUES WITH ANY TUBING JOINTS TO INCLUDE SCREWS, RIVETS AND WELDS. THERE WERE NO SIGNS OF DAMAGE, SUSPECT COMPONENTS, POOR WORKMANSHIP OR ANYTHING UNUSUAL TO REPORT. BASED UPON WHAT IS BEING REPORTED AND HOW THIS ITEM IS ASSEMBLED, IT IS HARD TO UNDERSTAND THE UNIT COMING APART BY HAVING A SCREW COME OUT. WE SUSPECT THIS WOULD HAVE BEEN NOTICED LONG BEFORE THE JOINT COMING APART. THE SCREWS USED TO HOLD THE TUBING FOR THE HORIZONTAL SIDE CROSS BARS IN PLACE HAVE A LONG ENGAGEMENT AND A TIGHT THREAD PATTERN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT GAVE WAY (LEFT BAR SCREW CAME OUT) DURING USE, CAUSING A PORTION OF THE WALKER TO SEPARATE. THE END USER FELL IN HIS ROOM AT THE FACILITY AND HAD SURGERY FOR A RIGHT TROCHANTERIC HIP FRACTURE. THE UNIT IS OWNED BY THE FACILITY WHERE THE INCIDENT OCCURRED. THE PRODUCT CARRIES A 250 LB. WEIGHT CAPACITY (113KG) AND, AS SUPPLIED, DOES NOT INCLUDE WHEELS. HOWEVER, THE "FACILILTY" ADDED WHEELS TO THE UNIT. THREE ATTEMPTS TO OBTAIN FURTHER DETAIL FROM THE FACILITY WERE MADE, WITH VERY LITTLE INFORMATION BEING PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72635 DMI® TWO-BUTTON RELEASE FOLDING WALKER WALKER ITJ VALENTINE INTERNATIONAL LIMITED 802-1044-0100 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention