BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESSORY DRAIN BAG

    MDR report key: 1904307 · Received November 14, 2010

    Report

    Report Number
    1904307
    Event Type
    Malfunction
    Date Received
    November 14, 2010
    Date of Event
    September 29, 2010
    Report Date
    November 14, 2010
    Manufacturer
    GAMBRO
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ACCESORY DRAIN BAGS WERE LEAKING FROM TWO LOTS. LOT 1023 AND ON BAG/LOT 0002171.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESSORY DRAIN BAG ACCESSORY DRAIN BAG KDI GAMBRO NA 1023; BAG LOT0002171
    2 ACCESSORY DRAIN BAG ACCESSORY DRAIN BAG KDI GAMBRO NA 1023; BAG LOT0002171

    Patients

    Seq Age Sex Outcome Treatment
    1 * DIALYSIS