BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER 500 URINEMETERS

    MDR report key: 4002204 · Received June 10, 2014

    Report

    Report Number
    3007966929-2014-00030
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    FFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THE DEVICE WAS USED ON A PATIENT, HOWEVER, THERE WAS NO REPORT OF HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED ON (B)(4) 2014, HOWEVER, NO ADDITIONAL INFORMATION REGARDING THIS INCIDENT COULD BE OBTAINED FROM THE REPORTER. PLEASE NOTE: REFERENCES ISSUE OCCURRED ON TWELVE (12) SEPARATE CASES. A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER (11) CASES UNDER PATIENT IDENTIFIER#(S): (B)(6). MANUFACTURER REPORT #(S): 3007966929-2014-00028, 29, 31, 32, 33, 34, 35, 36, 37, 38, 39 RESPECTIVELY. (REPORT 3 OF 12) TO DATE. SHOULD ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A RETURN SAMPLE FOR EVALUATION IS NOT EXPECTED. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    IT WAS REPORTED A NURSE OBSERVED THAT PATIENT'S BLADDER WAS FULL, BUT THE BAG WAS EMPTY SO SHE HAD TO MOVE THE DRAIN AND THE URINE STARTED TO FLOW. IT WAS ALSO STATE, "THE PROCEDURE IS MADE ALWAYS BY THE SERVICE NURSE WHO HAS LONG TIME EXPERIENCE WITH THESE PRODUCTS." NOTE: THIS REPORTED ISSUE OCCURRED ON TWELVE (12) SEPARATE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342986 UNOMETER 500 URINEMETERS DEVICE, URINE FLOW RATE MEASURING FFG UNOMEDICAL LTD. 158101310190 489760

    Patients

    Seq Age Sex Outcome Treatment
    1