BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER SAFETI PLUS, 110CM, 2L,RH

    MDR report key: 5153588 · Received October 15, 2015

    Report

    Report Number
    3007966929-2015-30316
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    March 15, 2011
    Report Date
    February 27, 2014
    Manufacturer
    UNOMEDICAL LTD
    Product Code
    FFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION (B)(4). 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 THE PRODUCT DID NOT DRAIN. THE PATIENT HAD A KIDNEY TRANSPLANT (B)(6) 2011. REOPERATED FOR BLEEDING 15. MARS. A SMALL AMOUNT OF URINE CAME DESPITE A LOT OF INTRAVENOUS FLUIDS BETWEEN 06AM TO 10AM. AS I TOUCH THE CATHETER TO CHECK, IT SPONTANEOUSLY COMES 350 ML URINE. THE CATHETER HAS A SMALL LOOP AND IS NOT SQUEEZED IN ANY WAY. AT 3 PM THE PATIENT CALLS AND HAS BLADDER BURST. I INVESTIGATE THE CATHETER ONCE AGAIN, AND BY TOUCHING IT, ANOTHER 550 ML URINE SPONTANEOUSLY IN TO THE CATHETER. IT IS NOT GOOD THAT THESE PATIENTS WHO ARE OPERATED ON THE BLADDER HAS A LARGE AMOUNT OF URINE IN THE BLADDER WITH THE RISK OF URINARY LEAKAGE / RUPTURE OF THE BLADDER. MANY OF THESE PATIENTS HAVE A VERY SMALL DIURESIS, AS THEY HAVE NOT URINATED ON THEIR OWN FOR SEVERAL YEARS. SINCE THIS IS AN EVENT THAT HAS OCCURRED SEVERAL TIMES AFTER WE GOT THE NEW SET. THE ISSUE IS REPORTED, ALTHOUGH THERE WAS NO HARM TO PATIENT, EXCEPT FROM DISCOMFORT WITH FULL BLADDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683026 UNOMETER SAFETI PLUS, 110CM, 2L,RH DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE FFG UNOMEDICAL LTD 158100510190

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR