BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD FLUORO-4 STENT

    MDR report key: 2852848 · Received November 27, 2012

    Report

    Report Number
    1018233-2012-01880
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 30, 2012
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    FAD
    PMA / PMN Number
    K823487
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS FORTHCOMING. ONCE THE SAMPLE IS RECEIVED AND EVALUATED, A MDR SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PRIOR TO BEING USED ON THE PATIENT, THE STENT BROKE ONCE REMOVED FROM IT'S ORIGINAL PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLUORO-4 STENT FAD PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGVC2787

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown