BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIDE MOBILITY PRODUCTS

    MDR report key: 3853685 · Received June 6, 2014

    Report

    Report Number
    2530130-2014-00042
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    April 30, 2014
    Report Date
    September 29, 2014
    Manufacturer
    PRIDE MOBILITY PRODUCTS
    Product Code
    INI
    PMA / PMN Number
    K063389
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. THE ALLEGED EVENT COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION AT THIS TIME. SHOULD FURTHER INFORMATION OR THE DEVICE BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED.

    Description of Event or Problem · 1

    CUSTOMER WAS IN EUROPE ON VACATION WHEN HE ALLEGES SCOOTERBEGAN TO FREEWHEEL UNCONTROLLABLY DOWN A HILL UNTIL HE CRASHED INTO A WALL AT THE BOTTOM.

    Description of Event or Problem · 1

    CUSTOMER WAS IN EUROPE ON VACATION WHEN HE ALLEGES SCOOTERBEGAN TO FREEWHEEL UNCONTROLLABLY DOWN A HILL UNTIL HE CRASHED INTO A WALL AT THE BOTTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332982 PRIDE MOBILITY PRODUCTS MOTORIZED THREE WHEELED VEHICLE INI PRIDE MOBILITY PRODUCTS SC44E N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization