BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER 500 - URINEMETERS

    MDR report key: 4340312 · Received December 10, 2014

    Report

    Report Number
    3007966929-2014-00129
    Event Type
    Malfunction
    Date Received
    December 10, 2014
    Date of Event
    October 28, 2014
    Report Date
    November 16, 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 INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE ARE A TOTAL OF NINE (9) CASES ASSOCIATED WITH THIS PRODUCT; THEREFOR,E NINE SEPARATE 3500A FORMS HAVE BEEN GENERATED TO ADDRESS THE OTHER CASES. THERE WERE NO REPORTS OF THE PT BEING HARMED AS A RESULT OF THIS MALFUNCTION. NO ADDITIONAL PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE HLTH CARE PROFESSIONAL STATED THE BURETTE CONTENTS DRAINED VERY SLOWLY - ALMOST AT A "TRICKLE" PACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797721 UNOMETER 500 - URINEMETERS URINE FLOW RATE MEASURING NON-ELECTR EXR UNOMEDICAL LTD. 158101310190 162015

    Patients

    Seq Age Sex Outcome Treatment
    1