BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER 500 - URINEMETERS

    MDR report key: 6000023 · Received October 5, 2016

    Report

    Report Number
    3007966929-2016-00088
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    November 19, 2015
    Report Date
    September 8, 2016
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    FFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXP DATE: 02/2020. DEVICE MANUFACTURE DATE:03/2016. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4). NOTE: THERE ARE TOTAL OF (3) CASES ASSOCIATED WITH THIS COMPLAINT. A SEPARATE 3500A FORM HAS BEEN COMPLETED TO FOR THE OTHER (2) CASES.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED. STERILIZATION WAS PERFORMED IN ACCORDANCE WITH PARAMETERS. THE BATCH WAS RELEASED ACCORDING TO REQUIREMENTS. A BATCH RECORD REVIEW INDICATED NO PREVIOUS DISCREPANCIES RELATED TO THE REPORTED COMPLAINT. THE INVESTIGATION ASSOCIATED WITH A NON-CONFORMANCE HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED AND THIS COMPLAINT WILL BE CLOSED. A PHYSICAL SAMPLE AND A PHOTO HAS BEEN RECEIVED FOR THIS COMPLAINT, WHICH WAS EVALUATED. DURING VISUAL INSPECTION IT WAS FOUND THAT TRACES OF CUT ARE PRESENT ON THE FOIL WHICH IS PARALLEL TO LONG SIDE OF INDIVIDUAL PACKAGE. TRACES OF CUT ARE PLACED CLOSED TO SEALING LINE. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING THAT "TRACES OF CUTS TO THE PACKAGING." THE REPORTED LOCATION OF THE CUTS WAS ON THE EDGE OF THE PRIMARY PACKAGING ON THE TRANSPARENT SIDE. THE CUTS WERE REPORTED TO BE FIVE CENTIMETERS (5 CM) LONG AND VERTICAL IN ASPECT. THREE PHOTOS WERE RECEIVED. ALL SHOW CUTS IN THE PRIMARY PACKAGING OF THIS STERILE PRODUCT. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651943 UNOMETER 500 - URINEMETERS DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE FFG UNOMEDICAL LTD. 25039742 229757

    Patients

    Seq Age Sex Outcome Treatment
    1