BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER SAFETI PLUS, 150CM, 1,5L,RH

    MDR report key: 5153590 · Received October 15, 2015

    Report

    Report Number
    3007966929-2015-30327
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    May 18, 2012
    Report Date
    February 27, 2014
    Manufacturer
    UNOMEDICAL LTD
    Product Code
    FFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL 2015-001-PRO AND PROTOCOL 2015-002-PRO. CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT URINE DOESN'T FLOW BETWEEN FOLEY CATHETER AND URINOMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684565 UNOMETER SAFETI PLUS, 150CM, 1,5L,RH DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE FFG UNOMEDICAL LTD 158100710190 636431

    Patients

    Seq Age Sex Outcome Treatment
    1