BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIDE

    MDR report key: 1618126 · Received February 25, 2010

    Report

    Report Number
    2530130-2010-00015
    Event Type
    Other
    Date Received
    February 25, 2010
    Date of Event
    January 25, 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

    THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED TO THE MFR; EVAL AND SERVICE WAS PERFORMED BY THE DEALER'S SERVICE GROUP. THE POWERCHAIR WAS NOT USED ACCORDING TO INSTRUCTIONS. 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 THAT WHILE TRAVELING ON A BUS SEATED IN HER POWERCHAIR, SHE WAS LAUNCHED OUT OF THE CHAIR WHEN THE BUS STOPPED. THE END USER SUSTAINED A KNEE INJURY THAT REQUIRED AN ER VISIT AND LEG BRACE. THE EVENT WAS REPORTED BY THE DEALER AS USER ERROR AND NEGLIGENCE.

    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 82 YR Hospitalization