BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 4861650 · Received June 17, 2015

    Report

    Report Number
    4861650
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 17, 2015
    Manufacturer
    MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS DELIVERED A WALKER AND THE WALKER WAS NOTICED TO BE FAULTY. THE HOLES IN THE FRONT LEG OF THE WALKER WERE NOT DRILLED STRAIGHT. THE HOLES ARE ANGLED CAUSING THE WALKER TO VIBRATE AND BOUNCE WHEN ROLLED ON HARD FLOORING. ALL THE WALKERS IN THE HOSPITAL INVENTORY WERE OBSERVED TO HAVE THE SAME DEFECT. ALL OF THE DEFECTIVE WALKERS WERE TAKEN OUT OF OUR STOCK. THE VENDOR THAT WE BUY THE WALKERS THROUGH SUPPLIED REPLACEMENTS TO EACH SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395657 * WALKER ITJ MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING 10210 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *