BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTATION CUSHION

    MDR report key: 2662537 · Received July 20, 2012

    Report

    Report Number
    1525712-2012-01002
    Event Type
    Malfunction
    Date Received
    July 20, 2012
    Report Date
    July 18, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    KIC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL ITFM, SERIAL NUMBER/DATE CODE (B)(4). THE OWNER'S MANUAL PART NUMBER 1141447 REV 8 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. ALLEGEDLY THE CUSHION FALLS OFF OF THE CHAIR.

    Description of Event or Problem · 1

    END USER STATES: "THAT THE CUSHION DOESN'T STAY IN PLACE AND FALLS OFF HIS SEAT AND WHEN IT FALLS HE HITS HIS LEG ON THE METAL PART OF HIS CHAIR WHICH HE STATED IS VERY PAINFUL FOR HIM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOTATION CUSHION 890.3175 KIC INVACARE TAYLOR STREET ITFM FG121505

    Patients

    Seq Age Sex Outcome Treatment
    1 80 Other