BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIDE

    MDR report key: 2101024 · Received May 24, 2011

    Report

    Report Number
    2530130-2011-00024
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 29, 2011
    Report Date
    July 18, 2011
    Manufacturer
    PRIDE MOBILITY PRODUCTS CORPORATION
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THE SCOOTER WENT BACKWARDS DOWN A RAMP; THE CUSTOMER SUSTAINED A FRACTURED ELBOW.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THE SCOOTER WENT BACKWARDS DOWN A RAMP; THE CUSTOMER SUSTAINED A FRACTURED ELBOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE SCOOTER INI PRIDE MOBILITY PRODUCTS CORPORATION SC63

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization