BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 1038340 · Received May 1, 2008

    Report

    Report Number
    2438477-2008-00003
    Event Type
    Injury
    Date Received
    May 1, 2008
    Date of Event
    December 27, 2006
    Report Date
    May 1, 2008
    Manufacturer
    HOMECARE ENTERPRISE CO., LTD
    Product Code
    IPS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE USER HAD BEEN USING THE CANE FOR ASSISTANCE IN WALKING DUE TO A LEG/KNEE PROBLEM. IN 2006, IT WAS ALLEGED THAT THE METAL LEVELING PIN SUDDENLY PUSHED INTO THE HOLE BY ITSELF, AND THE CANE COLLAPSED CAUSING THE USER TO FALL AND BREAK HIS WRIST. ACCORDING TO THE INITIAL REPORTER, THE USER SUFFERED SERIOUS FRACTURE THAT HAS REQUIRED SURGICAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL CANE IPS HOMECARE ENTERPRISE CO., LTD 10302-6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention