BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIDE

    MDR report key: 1620155 · Received February 25, 2010

    Report

    Report Number
    2530130-2010-00016
    Event Type
    Other
    Date Received
    February 25, 2010
    Date of Event
    February 8, 2010
    Report Date
    February 24, 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 - THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED TO THE MFR; EVAL AND SERVICE WAS PERFORMED BY THE DEALER'S SERVICE GROUP. RESULTS - THE DEALER SERVICE REPLACED THE ARMRESTS, AND CHARGER; THE POWERCHAIR WAS INSPECTED AND PERFORMED PROPERLY. CONCLUSIONS - THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE USER WAS EDUCATED ON PROPER USE OF PRODUCT.

    Description of Event or Problem · 1

    THE END USER ALLEGES, SHE WOKE UP IN THE MIDDLE OF THE NIGHT AND SOMEHOW GOT INTO POWERCHAIR; THE NEXT THING SHE KNEW, SHE AND THE POWERCHAIR TIPPED OVER. THE USER DOES NOT REMEMBER GETTING INTO THE POWERCHAIR; SHE SUSTAINED A BLACK EYE, BUMP ON THE HEAD, A BRUISED FOOT, AND WAS HOSPITALIZED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization