BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOTATION CUSHION

    MDR report key: 3932938 · Received July 14, 2014

    Report

    Report Number
    1525712-2014-03659
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 6, 2014
    Manufacturer
    UNKNOWN
    Product Code
    KIC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER STATED THAT THE ADHESIVE ON AN UNKNOWN GEL CUSHION IS NOT HOLDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411286 FLOTATION CUSHION 890.3175 KIC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other