BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITZ BATH 1616700692

    MDR report key: 4905335 · Received July 10, 2015

    Report

    Report Number
    1219590-2015-00109
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Report Date
    June 17, 2015
    Manufacturer
    INVACARE CLEVELAND STREET
    Product Code
    ILJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    WATER LEAKING AT THE BOTTOM OF THE TUB DOOR AROUND THE DOOR SEAL. THE TOP DOOR HINGE IS BENT AND NOT ALLOWING THE DOOR TO SEAL PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450180 SITZ BATH 1616700692 BATH, SITZ, NONPOWERED ILJ INVACARE CLEVELAND STREET IH3602GXL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other