BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMERSION HYDROBATH

    MDR report key: 2940265 · Received February 2, 2013

    Report

    Report Number
    1525712-2013-00743
    Event Type
    Malfunction
    Date Received
    February 2, 2013
    Report Date
    February 1, 2013
    Manufacturer
    INVACARE TAYLOR 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

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES TUB SEAL NEEDS TO BE REPLACED. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45446 IMMERSION HYDROBATH 890.5100 ILJ INVACARE TAYLOR STREET IH3750

    Patients

    Seq Age Sex Outcome Treatment
    1 Other