BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITZ BATH 1616700692

    MDR report key: 5070979 · Received September 11, 2015

    Report

    Report Number
    1219590-2015-00144
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Report Date
    August 18, 2015
    Manufacturer
    INVACARE CLEVELAND STREET
    Product Code
    KTC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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

    THE DEALER STATES THAT THE SEAL NEEDS TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603462 SITZ BATH 1616700692 BATH, SITZ, NONPOWERED KTC INVACARE CLEVELAND STREET IH3800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other