BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD INLAY LUBRICIOUS COATED DOUBLE PIGTAIL URETERAL STENT

    MDR report key: 3905631 · Received May 28, 2014

    Report

    Report Number
    1018233-2014-00122
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 13, 2014
    Report Date
    May 5, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    FAD
    PMA / PMN Number
    K983498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE THE STENT WAS FOUND BROKEN IN THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315127 BARD INLAY LUBRICIOUS COATED DOUBLE PIGTAIL URETERAL STENT FAD PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGXF2480

    Patients

    Seq Age Sex Outcome Treatment
    1