BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE POWER WHEELCHAIR

    MDR report key: 3040328 · Received October 2, 2007

    Report

    Report Number
    1525712-2007-00079
    Event Type
    Injury
    Date Received
    October 2, 2007
    Date of Event
    August 11, 2007
    Report Date
    September 24, 2007
    Manufacturer
    INVACARE CORP. - MANUFACTURING FACILITY
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    USER WAS REPORTEDLY MOVING OVER A THRESHOLD TOWARD A RAMP. THE RAMP INCLINE AND HEIGHT OF THRESHOLD ARE UNKNOWN AND NO INFORMATION PROVIDED IF RAILS WERE PRESENT ON THIS RAMP. DEVICE'S INCLINE CAPABILITY IS SPECIFIED FOR 9 DEGREES AND ITS THRESHOLD LIMIT IS 3 INCHES. INFORMATION INDICATES USER WAS NOT WEARING A SEAT POSITIONING STRAP. CHAIR HAD BEEN IN USE FOR OVER TWO YEARS PRIOR TO INCIDENT. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE OR ABUSE, OR LACK OF MAINTENANCE MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. AS A CONSERVATIVE MEASURE MDR FILED BASED ON ALLEGED INJURY.

    Description of Event or Problem · 1

    THE DEALER ALLEGES THE TEETH ON THE STABILITY LOCK ON THE RIGHT REAR OF THE CHAIR LOCKED UP, RAISING THE WHEEL OFF THE GROUND. THE CHAIR ALLEGEDLY PIVOTED TO THE RIGHT AND CONSUMER FELL OFF THEIR RAMP FROM THE CHAIR. SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE POWER WHEELCHAIR 890.3860 ITI INVACARE CORP. - MANUFACTURING FACILITY TDX5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention