BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER 500, URINE METER

    MDR report key: 4339731 · Received December 9, 2014

    Report

    Report Number
    3007966929-2014-00123
    Event Type
    Malfunction
    Date Received
    December 9, 2014
    Date of Event
    November 6, 2014
    Report Date
    November 14, 2014
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    EXR
    PMA / PMN Number
    K896732
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE ARE FIVE (5) ADDITIONAL CASES WITH SIMILAR PROBLEMS MANUFACTURED UNDER THE SAME LOT. ADDITIONAL MDR (3500A) REPORTS WILL BE SUBMITTED FOR EACH CASE. 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 INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A UNIT CLERK REPORTED ON BEHALF OF STAFF NURSES THE DEVICE'S TUBE DISCONNECTED FROM THE PATIENT'S CATHETER DURING USE. AS A RESULT URINE HAS LEAKED ONTO THE PATIENT'S BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793092 UNOMETER 500, URINE METER URINOMETER, MECHANICAL EXR UNOMEDICAL LTD. 25039742 158092

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown