BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER 500 - URINEMETERS

    MDR report key: 4320120 · Received December 3, 2014

    Report

    Report Number
    3007966929-2014-00104
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    October 28, 2014
    Report Date
    November 5, 2014
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    EXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE ARE A TOTAL OF NINE (9) CASES ASSOCIATED WITH THIS PRODUCT; THEREFORE NINE SEPARATE 3500A FORMS HAVE BEEN GENERATED TO ADDRESS THE OTHER CASES. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL STATED ONCE THE BURETTE WAS FILLED STAFF HAD DIFFICULTY DRAINING THE CONTENTS INTO THE END DRAINAGE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781353 UNOMETER 500 - URINEMETERS EXR UNOMEDICAL LTD. 158101310190 150587

    Patients

    Seq Age Sex Outcome Treatment
    1