BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTION STORM

    MDR report key: 299578 · Received October 4, 2000

    Report

    Report Number
    1525712-2000-00072
    Event Type
    Injury
    Date Received
    October 4, 2000
    Date of Event
    August 1, 2000
    Report Date
    September 12, 2000
    Manufacturer
    INVACARE CORPORATION
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER RECEIVED A REPORT FROM THE DEALER STATING THAT THE CONSUMER ALLEGES THE SEAT FRAME BROKE, CAUSING THE CONSUMER TO FALL OUT OF THE CHAIR. AS A RESULT THE USER SUSTAINED A BROKEN LEG.

    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