BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIDE

    MDR report key: 1941877 · Received December 30, 2010

    Report

    Report Number
    2530130-2010-00071
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    February 11, 2010
    Report Date
    March 9, 2011
    Manufacturer
    PRIDE MOBILITY PRODUCTS CORPORATION
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWERCHAIR WAS NOT RETURNED TO THE MANUFACTURER, HOWEVER THE MANUFACTURER SCHEDULED THE DEALER TO PERFORM THE EVALUATION ON THE ACTUAL DEVICE. THE SERVICE REPORT FROM THE DEALER INDICATED THAT THE POWERCHAIR WAS STORED FOR APPROXIMATELY ONE YEAR, WAS NOT FUNCTIONAL, AND WAS NOT MAINTAINED.

    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

    THE USER ALLEGES THAT WHEN SHE WAS AT A STATE FAIR, THE POWERCHAIR EJECTED HER AND SHE LANDED ON THE GROUND. THE USER SUSTAINED A BACK AND ANKLE INJURY REQUIRING HOSPITALIZATION.

    Description of Event or Problem · 1

    THE USER ALLEGES THAT WHEN SHE WAS AT A STATE FAIR, THE POWERCHAIR EJECTED HER AND SHE LANDED ON THE GROUND. THE USER SUSTAINED A BACK AND ANKLE INJURY REQUIRING HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE POWERCHAIR ITI PRIDE MOBILITY PRODUCTS CORPORATION 1420

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization