BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIDE

    MDR report key: 1870151 · Received October 12, 2010

    Report

    Report Number
    2530130-2010-00054
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 24, 2010
    Report Date
    October 7, 2010
    Manufacturer
    PRIDE MOBILITY PRODUCTS CORP.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWERCHAIR WAS NOT EVALUATED BY THE MFR, HOWEVER, IS FUNCTIONAL, AND STILL IN USE WITH THE USER. THE EVENT WAS DUE TO USER ERROR. THE EVENT WAS NOT PRODUCT RELATED; IT IS BEING REPORTED DUE TO THE SUSTAINED INJURY.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES HE GOT HIS FOOT STUCK IN BETWEEN THE FOOTREST AND WHEEL DURING A TRANSFER; THE CUSTOMER FELL AND SUSTAINED A FRACTURED RIGHT LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE POWERCHAIR ITI PRIDE MOBILITY PRODUCTS CORP. SELECT 6 ULTRA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention