BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX FOLEY CATHETER

    MDR report key: 3851309 · Received May 23, 2014

    Report

    Report Number
    1018233-2014-00113
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    December 18, 2013
    Report Date
    April 28, 2014
    Manufacturer
    C.R. BARD, INC. (MONCKS)
    Product Code
    EZC
    PMA / PMN Number
    K190846
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    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 A 16 FRENCH LATEX FOLEY CATHETER WAS PLACED IN THE PATIENT AT THE END OF A CYSTO WITH STENT PLACEMENT PROCEDURE. THE FOLEY WOULD NOT PASS THE PATIENT'S URETHRA. THE PHYSICIAN THEN NOTED TRAUMA TO THE PATIENT'S POSTERIOR URETHRA. A 16 FRENCH COUNCIL TIP CATHETER WAS PLACED WITHOUT FURTHER IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307803 LATEX FOLEY CATHETER EZC C.R. BARD, INC. (MONCKS) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention