BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 2072133 · Received April 28, 2011

    Report

    Report Number
    2530130-2011-00016
    Event Type
    Death
    Date Received
    April 28, 2011
    Date of Event
    September 18, 2010
    Report Date
    October 5, 2011
    Manufacturer
    PRIDE MOBILITY PRODUCTS
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED. NO DESIGN OR BUILD SPECIFICATION OR FUNCTION COULD BE ATTRIBUTED TO THE INCIDENT. THE NATURE OF THE COMPLAINT INCLUDING HOW THE END USER GOT STUCK AND THE SUBSEQUENT ACTIONS ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGEDLY DROVE HER SCOOTER TO THE TOP OF A RAMP, AND GOT STUCK. IN ATTEMPTS TO GET FREE, SHE PUSHED HERSELF AWAY AND PRESSED THE THROTTLE. THE SCOOTER DROVE TOWARD STEPS, STOPPED, AND THE CUSTOMER FELL DOWN THE STEPS; THE CUSTOMER PASSED AWAY AS A RESULT OF THE INJURIES.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGEDLY DROVE HER SCOOTER TO THE TOP OF A RAMP, AND GOT STUCK. IN ATTEMPTS TO GET FREE, SHE PUSHED HERSELF AWAY AND PRESSED THE THROTTLE. THE SCOOTER DROVE TOWARD STEPS, STOPPED, AND THE CUSTOMER FELL DOWN THE STEPS; THE CUSTOMER PASSED AWAY AS A RESULT OF THE INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE MOBILITY PRODUCTS MOTORIZED THREE-WHEELED VEHICLE INI PRIDE MOBILITY PRODUCTS SC44E

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death