BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMERSION HYDROBATH

    MDR report key: 3776389 · Received April 28, 2014

    Report

    Report Number
    1219590-2014-00074
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Report Date
    March 27, 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

    DEALER STATED THAT THE DOOR SEAL ON AN IH3650 SIDE ENTRY TUB IS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255049 IMMERSION HYDROBATH 890.5100 ILJ INVACARE CLEVELAND STREET IH3650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other