BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITZ BATH 1616700692

    MDR report key: 4973614 · Received August 5, 2015

    Report

    Report Number
    1219590-2015-00122
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Report Date
    July 13, 2015
    Manufacturer
    INVACARE CLEVELAND STREET
    Product Code
    KTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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

    DOOR SEAL LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517010 SITZ BATH 1616700692 BATH, SITZ, NONPOWERED KTC INVACARE CLEVELAND STREET IH3600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other