BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER¿ SAFETI¿ PLUS - WITH LUER-LOCK & LUER

    MDR report key: 6080392 · Received November 4, 2016

    Report

    Report Number
    3007966929-2016-00100
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    FFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A PRODUCT MALFUNCTION. NO PATIENT HARM WAS REPORTED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE "WAS TO BE USED IN THEATRE FOR A PROCEDURE. A HAIR WAS NOTICED TO BE SEALED IN THE STERILE PACKAGE." DEVICE WAS NOT USED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729524 UNOMETER¿ SAFETI¿ PLUS - WITH LUER-LOCK & LUER DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE FFG UNOMEDICAL LTD. 413455

    Patients

    Seq Age Sex Outcome Treatment
    1