BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTATION CUSHION

    MDR report key: 3843916 · Received June 2, 2014

    Report

    Report Number
    3007582653-2014-00001
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    February 25, 2014
    Manufacturer
    INVACARE (LTD) UK
    Product Code
    KIC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT GEL FROM THE FT1820 MATRX FLO TECH CUSHION LEAKED OUT ONTO THE FLOOR CAUSING THE USER TO FALL WHEN EXITING THEIR UNKNOWN WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321560 FLOTATION CUSHION 890.3175 KIC INVACARE (LTD) UK FT1820

    Patients

    Seq Age Sex Outcome Treatment
    1 62 Other