BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITZ BATH 1616700692

    MDR report key: 5069327 · Received September 10, 2015

    Report

    Report Number
    1219590-2015-00143
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Report Date
    August 17, 2015
    Manufacturer
    INVACARE CLEVELAND STREET
    Product Code
    ILJ
    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

    SEAL IS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599650 SITZ BATH 1616700692 BATH, SITZ, NONPOWERED ILJ INVACARE CLEVELAND STREET IH3650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other