BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 2211949 · Received August 15, 2011

    Report

    Report Number
    2530130-2011-00035
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 29, 2011
    Report Date
    October 5, 2011
    Manufacturer
    PRIDE MOBILITY PRODUCTS
    Product Code
    INI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR EVALUATION. WILL SUBMIT A FOLLOW-UP INVESTIGATION REPORT SHOULD THE DEVICE BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATION AND THE ALLEGED COMPLAINT COULD NOT BE REPLICATED DURING AN EXTENSIVE TEST RIDE.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES SCOOTER SPEED RAMPED UP WHILE HE WAS DRIVING IN HIS HOME HALLWAY RESULTING IN INJURY.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES SCOOTER SPEED RAMPED UP WHILE HE WAS DRIVING IN HIS HOME HALLWAY RESULTING IN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE MOBILITY PRODUCTS MOTORIZED THREE-WHEELED VEHICLE INI PRIDE MOBILITY PRODUCTS SC4001

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization