BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON URINARY DRAIN BAG WITH FLUTTER VALVE

    MDR report key: 2577538 · Received May 10, 2012

    Report

    Report Number
    1451040-2012-00008
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 15, 2012
    Manufacturer
    CONOD MEDICAL CO. LTD.
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT THE CLINICAL USERS OF THE URINARY DRAINAGE BAG HAD CONCERNS WITH URINE BACKING UP IN THE OUTFLOW TUBE AND LEAKAGE OF THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCKESSON URINARY DRAIN BAG WITH FLUTTER VALVE URINARY DRAIN BAG KNX CONOD MEDICAL CO. LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK