BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 863248 · Received June 8, 2007

    Report

    Report Number
    2438477-2007-00001
    Event Type
    Injury
    Date Received
    June 8, 2007
    Date of Event
    May 10, 2007
    Report Date
    May 21, 2007
    Manufacturer
    MEDICAL DEPOT INC. (D/B/A DRIVE MEDICAL DESIGN & MFG)
    Product Code
    NXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE APPEARED TO BE USED FOR A PERIOD OF TIME. THE RIGHT REAR LEG IS BROKEN OFF COMPLETELY AT WHERE THE LOWER RIVET ATTACHED TO THE SIDE CROSS BAR. THE FOLDING/LATCHING MECHANISM APPEARED TO WORK PROPERLY. WE BELIEVE THAT THE DEVICE BROKE BECAUSE THE USER APPLIED WEIGHT TO ONLY ONE LEG WHILE WALKING ON STEPS. OUR PRODUCT INSTRUCTION HAS A WARNING FOR THE USER NOT TO USE ON STAIRS OR ESCALATORS.

    Description of Event or Problem · 1

    USER ALLEGEDLY WAS IN THE KITCHEN, WALKED DOWN HALLWAY AND PROCEEDED TO GO UP APPROX NINE (9) STEPS WHEN ALLEGEDLY THE LEG OF THE WALKER ALLEGEDLY SNAPPED AND USER TUMBLED DOWN THE STAIRWAY. USER DOES NOT RECALL THE FALL. USER BROKE HIS RIGHT HIP AND FRACTURED HIS PELVIC BONE. FAMILY MEMBERS CALLED 911. USER WAS TRANSPORTED AND ADMITTED TO HOSP IN 2007. AFTER TREATMENT AND STABILIZATION, USER WAS THEN TRANSPORTED FIVE DAYS LATER TO REHAB. AS OF THREE DAYS LATER, USER WAS STILL IN REHAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL MECHANICAL WALKER NXE MEDICAL DEPOT INC. (D/B/A DRIVE MEDICAL DESIGN & MFG) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization