BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIDE

    MDR report key: 1637737 · Received March 19, 2010

    Report

    Report Number
    2530130-2010-00027
    Event Type
    Other
    Date Received
    March 19, 2010
    Date of Event
    March 13, 2010
    Report Date
    March 18, 2010
    Manufacturer
    PRIDE MOBILITY PRODUCTS CORPORATION
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE MOTORS FAILED WHILE THE CUSTOMER WAS DRIVING THE POWERCHAIR DOWN A HILL IN HIS YARD; THE CUSTOMER FELL OUT OF THE CHAIR AND SUSTAINED A BROKEN LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE POWERCHAIR ITI PRIDE MOBILITY PRODUCTS CORPORATION Q6000Z NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization