BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER SAFETI+,150CM,2L,RH

    MDR report key: 5984239 · Received September 28, 2016

    Report

    Report Number
    3007966929-2016-00087
    Event Type
    Malfunction
    Date Received
    September 28, 2016
    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

    EXPIRATION DATE: 11/2019. MANUFACTURE DATE: 12/2015. 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. REPORTED TO THE FDA ON SEPTEMBER 28, 2016. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE BATCH WAS RELEASED ACCORDING TO REQUIREMENTS. THE MANUFACTURER DID NOT FIND ANY NONCONFORMITY DURING THE PRODUCTION LOT. ALL RELEVANT TESTS DURING PRODUCTION OF THE AFFECTED LOT# 223486 WERE PERFORMED, REGISTERED AND THE RESULTS WERE IN COMPLIANCE WITH REQUIREMENTS. MACHINE LOGBOOKS WERE CHECKED. DUE TO TECHNICAL PROBLEMS WITH THE TEARING STATION AND THE CHANGE OF THE GRIPPERS AT THE TEARING SYSTEM THESE WERE REGISTERED IN THE MACHINE LOGBOOKS AND THE PRODUCTION STAFF WAS NOTIFIED OF THE DEFECT. A QUERY WAS RUN AGAINST LOT# 223486 WHICH YIELDED 7 ASSOCIATED OCCURRENCES. A NON-CONFORMANCE (NC) WAS OPENED AND INVESTIGATED IN AN ASSOCIATED COMPLAINT. THE NC HAS BEEN CLOSED AND NO ADDITIONAL ACTION IS REQUIRED AND THIS COMPLAINT WILL BE CLOSED. 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. REPORTED TO THE FDA ON OCTOBER 20, 2016. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING THAT "THERE IS A LEAK BETWEEN THE CHAMBER AND THE POUCH AT THE TOP OF THE POUCH." NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635333 UNOMETER SAFETI+,150CM,2L,RH DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE FFG UNOMEDICAL LTD. 158101310190 223486

    Patients

    Seq Age Sex Outcome Treatment
    1