BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNO UNOMETER 500 150CM BO H

    MDR report key: 4840426 · Received June 11, 2015

    Report

    Report Number
    3007966929-2015-00056
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 2, 2015
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    FFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A QUALITY COMPLAINT INVESTIGATION WAS PERFORMED. A COMPLAINT SAMPLE WAS NOT RECEIVED FROM THE CUSTOMER. NO NON-CONFORMANCE FOR THE COMPLAINT ORDER RELATED TO THE COMPLAINT ISSUE WAS INITIATED. CORRECTIVE ACTION "RETRAIN OF OPERATORS ACCORDING TO C805007" WAS INITIATED AND IMPLEMENTED ON THE BASIS OF A PREVIOUS EVENT. THE COMPLAINT LOT WAS PRODUCED BEFORE IMPLEMENTATION OF THE CORRECTIVE ACTION. ADDITIONALLY, THE CORRECTIVE ACTION "TO ORDER PLASTIC BOXES FOR PRODUCTION" WAS INITIATED. THE CORRECTIVE ACTION IS IN PROGRESS. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADD'L INFO BECOME AVAILABLE, A F/U REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WAS NO REPORT OF PT INVOLVEMENT. ADD'L INFO HAS BEEN REQUESTED. SHOULD INFO BE PROVIDED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A HAIR WAS FOUND IN THE DEVICE PACKAGING UNDER THE CAP CONNECTION. THE PROD WAS NOT USED ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381453 UNO UNOMETER 500 150CM BO H DEVICE, URINE FLOW RATE MEASURING FFG UNOMEDICAL LTD. 25041182 155637

    Patients

    Seq Age Sex Outcome Treatment
    1