BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 974708 · Received December 21, 2007

    Report

    Report Number
    2438477-2007-00006
    Event Type
    Injury
    Date Received
    December 21, 2007
    Date of Event
    September 20, 2007
    Report Date
    November 20, 2007
    Manufacturer
    HOMECARE ENTERPRISE CO. LTD.
    Product Code
    IPS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USER PURCHASED THE CANE IN OR ABOUT SEPTEMBER, 2006. AFTER ONE-YEAR OF USE, IN 2007, THE USER USED THE SUSPECT DEVICE TO ASSIST HIM DURING A VERY LONG WALK IN WHICH ENDED WITH THE USER STANDING IN LINE TO PURCHASE SHOW TICKETS. DURING HIS WAITING, THE USER OPENED THE DEVICE'S FOLD DOWN SEAT AND SAT DOWN TO REST AS HE WAITED ON THE TICKET LINE. THE DEVICE ALLEGEDLY COLLAPSED AND HURLED THE USER BACKWARDS TO THE PAVEMENT AND ALLEGEDLY CAUSED HIM TO SUFFER SERIOUS AND PERMANENT INJURY. DETAILED INFORMATION ON USER INJURIES AND THE SUSPECT DEVICE IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRIVE MEDICAL CANE SEAT IPS HOMECARE ENTERPRISE CO. LTD. 10365 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization