BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 1217572 · Received October 22, 2008

    Report

    Report Number
    2438477-2008-00010
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    August 11, 2008
    Report Date
    September 23, 2008
    Manufacturer
    JAN MAO INDUSTRIES CO., LTD.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE THE PATIENT WAS WALKING, ACCOMPANIED BY HER PRIVATE CAREGIVER AND THE WALKER, ALLEGEDLY ONE OF THE WHEELS FELL CAUSING THE PATIENT TO FALL. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL BY AMBULANCE, AND WAS RELEASED FROM ER THE SAME DAY. ALLEGEDLY THE PATIENT WAS DIAGNOSED WITH AND TREATED FOR BLACK EYE AND LACERATIONS. SHE WENT BACK TO THE HOSPITAL FOR A FOLLOW-UP WOUND CHECK TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL WALKER ITJ JAN MAO INDUSTRIES CO., LTD. 10230 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention