BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMERSION HYDROBATH

    MDR report key: 3212080 · Received July 8, 2013

    Report

    Report Number
    1219590-2013-00056
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 14, 2013
    Manufacturer
    INVACARE CLEVELAND STREET
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE TUB IS LEAKING AT THE DOOR SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309816 IMMERSION HYDROBATH 890.5100 ILJ INVACARE CLEVELAND STREET IH3800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other