BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX LUBRICATH 2-WAY 5CC LATEX FOLEY CATHETER

    MDR report key: 3890759 · Received June 12, 2014

    Report

    Report Number
    1018233-2014-00149
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BARD SDN. BHD.
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LATEX FOLEY CATHETER WAS USED ON A LATEX SENSITIVE PATIENT. IT WAS DISCOVERED THAT THE PATIENT WAS LATEX SENSITIVE APPROXIMATELY 5-10 MINUTES AFTER THE CATHETER WAS INSERTED. THE CATHETER WAS THEN REMOVED AND A NON-LATEX FOLEY CATHETER WAS PLACED. UPON COMPLETION OF THE PROCEDURE, THE PATIENT WAS TAKEN TO RECOVERY WITH NO OBVIOUS SIDE EFFECTS FROM THE LATEX FOLEY CATHETER. APPROXIMATELY 4-5 HOURS POST OP, THE PATIENT EXPERIENCED A SWOLLEN TONGUE, HANGING OUTSIDE OF THE PATIENT'S MOUTH. THE PATIENT WAS TAKEN TO THE ICU FOR MONITORING AND WAS TREATED WITH BENADRYL AND IV FLUIDS. THE PATIENT HAS FULLY RECOVERED FROM THE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347746 BARDEX LUBRICATH 2-WAY 5CC LATEX FOLEY CATHETER EZC BARD SDN. BHD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention