BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3901899 · Received June 30, 2014

    Report

    Report Number
    1525712-2014-03291
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    May 29, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PER CUSTOMER HE WAS DRIVING DOWN ROAD WHEN FRONT RIGHT WHEEL CAVED UNDER CHAIR PER CUSTOMER THE CHAIR IS JUNK. HE STATES THAT HE HAS REPLACED THE BATTERY, 2 JOYSTICKS, TIRES, AND BEARINGS. OUR RECORDS ONLY INDICATE ORDER (B)(4) FROM OCTOBER FOR A JOYSTICK FOR THE RECALL. THE CURRENT ISSUE HAS TO DO WITH HIS RIGHT FRONT WHEEL. HE WAS THROWN OUT OF THE CHAIR AND BRUISING HIS RIBS. HE STATES THAT HE HAS CEREBRAL PALSY. ADVISED MR. (B)(4) THAT I WOULD CALL THE PROVIDER. MRS DOES NOT SHOW ANY RECENT REPAIRS. THEY ARE CHECKING WITH ANOTHER LOCATION AND WILL CALL ME BACK. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380333 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R