BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMERSION HYDROBATH

    MDR report key: 3964506 · Received July 29, 2014

    Report

    Report Number
    1219590-2014-00113
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    June 20, 2014
    Manufacturer
    INVACARE CLEVELAND STREET
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY STATES THAT THE TUB IS LEAKING WATER WHERE THE PLASTIC TUBES CONNECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441076 IMMERSION HYDROBATH 890.5100 ILJ INVACARE CLEVELAND STREET IH3650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other