BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVER MEDICAL

    MDR report key: 893206 · Received August 10, 2007

    Report

    Report Number
    2438477-2007-00002
    Event Type
    Injury
    Date Received
    August 10, 2007
    Date of Event
    July 11, 2007
    Report Date
    July 11, 2007
    Manufacturer
    MEDICAL DEPOT INC. (D/B/A DRIVE MEDICAL DESIGN AND MFG)
    Product Code
    NXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US

    Narratives

    Additional Manufacturer Narrative · 1

    ALL OUR ROLLATORS ARE DISTRIBUTED WITH ALL CASTERS PREINSTALLED. THE FRONT CASTER FORK IS INSTALLED TO THE FRAME BY AN AXLE BOLT AND LOCK WASHER. ACCORDING TO CUSTOMER, THIS ROLLATOR HAD BEEN USED FOR DEMONSTRATION IN SHOWROOMS FOR MORE THAN TWO YRS. IT APPEARED THAT THE WHEEL CAME LOOSE DUE TO LACK OF MAINTENANCE.

    Description of Event or Problem · 1

    THE USER ALLEGEDLY WAS TRYING TO SIT ON THE ROLLATOR TO TEST THE PRODUCT WHEN THE LEFT CASTER FELL OUT. SHE CONSEQUENTLY FELL BACKWARDS SUSTAINING SEVERE CUTS ON THE RIGHT CALF AND RIGHT ELBOW. MEDICAL ATTENTION WAS REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention