BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINARY DRAINAGE BAGS

    MDR report key: 3917797 · Received June 30, 2014

    Report

    Report Number
    3005778470-2014-00039
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    April 29, 2014
    Report Date
    June 4, 2014
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS FURTHER REPORTED THAT THE URINARY BAG AS REMOVED DUE TO PAIN THE PT HAD. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED. REPORTED TO FDA ON JUNE 27, 2014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE COMPLAINANT STATED "URINE DIDN'T FLOW IN THE URINARY BAG THROUGH THE HOSE INSTEAD IT STAYED IN PT'S URINE BLADDER WHICH CAUSES PAIN. THERE WAS NO VISIBLE REASON FOR THE INCIDENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378907 URINARY DRAINAGE BAGS COLLECTOR, URINE, (AND ACCESSORIES) KNX UNOMEDICAL S.R.O. 38 115 1S-10 393785

    Patients

    Seq Age Sex Outcome Treatment
    1