BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRIDE

    MDR report key: 2228162 · Received January 21, 2009

    Report

    Report Number
    2530130-2009-00003
    Event Type
    Other
    Date Received
    January 21, 2009
    Date of Event
    November 27, 2006
    Report Date
    January 19, 2009
    Manufacturer
    PRIDE MOBILITY PRODUCTS CORP.
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO PENDING LITIGATION, A DEVICE EVAL CANNOT BE COMPLETED AT THIS TIME. CANNOT DRAW ANY CONCLUSIONS AT THIS TIME. A F/U REPORT WILL BE SUBMITTED IF THE DEVICE IS MADE AVAILABLE TO PRIDE FOR EVAL.

    Description of Event or Problem · 1

    RECEIVED A LETTER FROM AN ATTORNEY ALLEGING THE END USER WAS OPERATING HIS SCOOTER IN HIS APARTMENT WHEN THE SCOOTER ACCELERATED FORWARD CAUSING THE END USER TO RUN INTO A WALL. THE END USER SUSTAINED SOFT TISSUE INJURIES TO HIS NECK AND SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIDE SCOOTER ITI PRIDE MOBILITY PRODUCTS CORP. SC3450 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention