BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMERSION HYDROBATH

    MDR report key: 3910245 · Received July 2, 2014

    Report

    Report Number
    1219590-2014-00096
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    May 29, 2014
    Manufacturer
    INVACARE CLEVELAND STREET
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER DEALER, THE DOOR SEAL IS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386564 IMMERSION HYDROBATH 890.5100 ILJ INVACARE CLEVELAND STREET IH3650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other