BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINARY DRAINAGE BAGS

    MDR report key: 3894328 · Received February 19, 2014

    Report

    Report Number
    3005778470-2014-00006
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 24, 2014
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    FCN
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS REPORTED THAT THE PT DEVELOPED A URINARY TRACT INFECTION. NO ADD'L EVENT/PT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD A SAMPLE OR ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014.

    Description of Event or Problem · 1

    COMPLAINANT REPORTED PT DEVELOPING URINARY RETENTION AS URINE UNABLE TO FLOW THROUGH TUBING INTO BAG AT CONNECTION SITE AT TOP OF BAG. THE PRODUCT WAS IN USE FOR 12-18 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104706 URINARY DRAINAGE BAGS KIT, URINARY DRAINAGE COLLECTION FCN UNOMEDICAL S.R.O. 38 155 1S 445171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention