BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITZ BATH 1616700692

    MDR report key: 4379280 · Received January 5, 2015

    Report

    Report Number
    1219590-2014-00223
    Event Type
    Malfunction
    Date Received
    January 5, 2015
    Report Date
    December 11, 2014
    Manufacturer
    INVACARE CLEVELAND STREET
    Product Code
    KTZ
    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

    IT HAS BEEN REPORTED BY A DEALER THAT A DOOR SEAL IS LEAKING ON AN IH3802G TUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2581 SITZ BATH 1616700692 BATH, SITZ, NONPOWERED KTZ INVACARE CLEVELAND STREET IH3802G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other