BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIDE

    MDR report key: 1631485 · Received March 12, 2010

    Report

    Report Number
    2530130-2010-00017
    Event Type
    Other
    Date Received
    March 12, 2010
    Date of Event
    February 17, 2010
    Report Date
    March 1, 2010
    Manufacturer
    PRIDE MOBILITY PRODUCTS CORP.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NOT A PRODUCT PROBLEM, MDR REPORTED DUE TO INJURY; USER ERROR. RESULTS: USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER WAS GETTING OUT OF BED, WITH HER DAUGHTER ASSISTING HER. WHEN THE DAUGHTER LEANED OVER, SHE TURNED THE POWERCHAIR ON WITH HER CHEST. THE CHAIR TOOK OFF INTO THE CUSTOMER, HITTING HER. THE END USER SUSTAINED A FRACTURED TIBIA AND WAS HOSPITALIZED FOR A DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE POWERCHAIR ITI PRIDE MOBILITY PRODUCTS CORP. JAZZY SELECT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization