BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMERSION HYDROBATH

    MDR report key: 3222889 · Received July 12, 2013

    Report

    Report Number
    1219590-2013-00059
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    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

    PROVIDER STATES THE TUB DOOR SEALS ARE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323590 IMMERSION HYDROBATH 890.5100 ILJ INVACARE CLEVELAND STREET IH3650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other