BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTION STORM

    MDR report key: 308126 · Received December 7, 2000

    Report

    Report Number
    1525712-2000-00094
    Event Type
    Injury
    Date Received
    December 7, 2000
    Date of Event
    June 1, 2000
    Report Date
    November 20, 2000
    Manufacturer
    INVACARE CORPORATION
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED A LETTER ALLEGING THE ENDUSER FELL OUT OF THE WHEELCHAIR WHEN THE LEFT ARMREST DETACHED FROM THE WHEELCHAIR. THIS RESULTED IN A FRACTURED HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTION STORM POWERED WHEELCHAIR ITI INVACARE CORPORATION STORM ARROW / TORQUE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention