BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX ALL SILICONE FOLEY CATHETER

    MDR report key: 3901987 · Received February 24, 2014

    Report

    Report Number
    1018233-2014-00044
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Report Date
    January 31, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    EZL
    PMA / PMN Number
    K040504
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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 UPON DEFLATION OF THE CATHETER A RIDGE FORMED ALONG THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114373 BARDEX ALL SILICONE FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGTF2879

    Patients

    Seq Age Sex Outcome Treatment
    1