BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTATION CUSHION

    MDR report key: 3013926 · Received March 20, 2013

    Report

    Report Number
    1525712-2013-02135
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    KIC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE PBE1616 MATRX ELITE CUSHION BACK LEFT TOP HARDWARE WERE LOOSE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115274 FLOTATION CUSHION 890.3175 KIC INVACARE TAYLOR STREET PBE1616

    Patients

    Seq Age Sex Outcome Treatment
    1 Other