BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMERSION HYDROBATH

    MDR report key: 4090049 · Received September 15, 2014

    Report

    Report Number
    1219590-2014-00142
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 21, 2014
    Manufacturer
    INVACARE CLEVELAND STREET
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THE DOOR SEAL IS LEAKING ON A IH3602GXL TUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569691 IMMERSION HYDROBATH 890.5100 ILJ INVACARE CLEVELAND STREET IH3602GXL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other