BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMOBIL C300 PS

    MDR report key: 2969699 · Received February 11, 2013

    Report

    Report Number
    1221084-2013-00002
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 31, 2012
    Report Date
    February 8, 2013
    Manufacturer
    PERMOBIL, INC.
    Product Code
    ITI
    PMA / PMN Number
    K041219
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE BACK CANES ON THE BACKREST OF THE POWER WHEELCHAIR FAILED AND THE CLIENT FELL BACKWARD. THE CLIENT SUFFERED A CUT ON HIS HEAD. DEALER PROVIDED INFORMATION INDICATING THAT PUBLIC TRANSPORTATION INAPPROPRIATELY SECURED THE WHEELCHAIR BY ATTACHING THE TIE DOWNS TO THE BACK CANES. THIS SITUATION PLACED SIGNIFICANT STRESS ON THE BACK CANES CAUSING THEM TO BREAK. THE WHEELCHAIR HAS DESIGNATED AREAS PROPERLY MARKED WHERE TIE DOWNS SHOULD BE ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60049 PERMOBIL C300 PS POWER WHEELCHAIR ITI PERMOBIL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other