BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE KNEE WALKER

    MDR report key: 4673432 · Received March 26, 2015

    Report

    Report Number
    4673432
    Event Type
    Malfunction
    Date Received
    March 26, 2015
    Date of Event
    March 25, 2015
    Report Date
    March 26, 2015
    Manufacturer
    MEDICAL DEPOT, INC.
    Product Code
    ITJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICAL THERAPIST WAS TRANSFERRING THE PATIENT OUT OF BED AND ONTO A KNEE WALKER. THE PATIENT HAD A GAIT BELT AROUND HIS WAIST. HE SAT UP ON EDGE OF BED. HE PLACED HIS KNEE ON THE KNEE REST ON THE WALKER. HE THEN PLACED HIS HANDS ON THE HANDLE OF THE WALKER AND ATTEMPTED TO STAND UP. THE HANDLE TELESCOPED DOWN AND THE PATIENT LOST HIS BALANCE. THE THERAPIST USED THE GAIT BELT TO PULL HIM BACK ONTO THE BED. THE THERAPIST CHECKED THE HANDLE OF THE WALKER AND IT WAS LOCKED IN PLACE BUT IT STILL TELESCOPED DOWN WHEN HE APPLIED HIS WEIGHT. THE MANUFACTURER'S TAG ON THE KNEE WALKER SAYS THE WALKER HOLDS UP TO 136 KG/300 POUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201781 DRIVE KNEE WALKER WALKER, MECHANICAL ITJ MEDICAL DEPOT, INC. HX5 9JP 3H140665389

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR