BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAILY ACTIVITY ASSIST DEVICES-UTENSIL FOR DRESSING, GROOMING, RECREAT

    MDR report key: 1662394 · Received April 16, 2010

    Report

    Report Number
    1525712-2010-00050
    Event Type
    Injury
    Date Received
    April 16, 2010
    Date of Event
    February 22, 2010
    Report Date
    April 16, 2010
    Manufacturer
    INVACARE
    Product Code
    ILZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDWATCH FORM WAS RECEIVED ON 04/05/2010 (B) (6) PROVIDING ADD'L INFO. NO INJURY TO THE PT HAS OCCURRED. PHOTOS WERE PROVIDED, AND IT IS APPARENT THE TRAPEZE WAS NOT ASSEMBLED PROPERLY. THE FACILITY INDICATES THE DEVICE WAS ASSEMBLED BY THE DISTRIBUTOR WITHIN THIS MEDWATCH FORM. PHOTOS PROVIDED INDICATED THAT THE DEVICE WAS NOT FULLY SEATED IN THE BASE. THE FACILITIES ATTENDANT ALLEGEDLY SUSTAINED AN INJURY. NO MALFUNCTION APPARENT. MDR FILED AS A CONSERVATIVE MEASURE.

    Description of Event or Problem · 1

    THE FACILITY STATES THERE WERE TWO EMPLOYEES ASSISTING THE CONSUMER. THE CONSUMER WAS HOLDING THE TRAPEZE BAR AND PULLING DOWN WHEN THE VERTICAL BAR ALLEGEDLY BENT, CAUSING THE DEVICE TO BEND FORWARD AND HIT THE EMPLOYEE ASSISTANT ON THE HEAD. THIS ALLEGEDLY RESULTED IN A CONCUSSION TO THE EMPLOYEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAILY ACTIVITY ASSIST DEVICES-UTENSIL FOR DRESSING, GROOMING, RECREAT 890.5050 ILZ INVACARE 7740P RP090814

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention