BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER

    MDR report key: 3982911 · Received July 2, 2014

    Report

    Report Number
    1018233-2014-00169
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    June 13, 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
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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 REMOVAL OF THE CATHETER FROM THE URETHRA'S RIDGE WAS NOTED AT THE TIP OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387053 BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER EZL PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1