BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX FOLEY CATHETER

    MDR report key: 6177756 · Received December 15, 2016

    Report

    Report Number
    1018233-2016-01820
    Event Type
    Injury
    Date Received
    December 15, 2016
    Report Date
    December 15, 2016
    Manufacturer
    BARD SDN. BHD. -8040607
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "THIS PRODUCT CONTAIN NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED TO DRAIN THE URINE AFTER SURGERY. AS A RESULT, A WEEK LATER, THE PATIENT SUFFERED A URINARY TRACT INFECTION AND HAD TO UNDERGO AN ANTI-INFECTION TREATMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOLEY CATHETER WAS PLACED TO DRAIN THE URINE AFTER SURGERY. AS A RESULT, A WEEK LATER, THE PATIENT SUFFERED A URINARY TRACT INFECTION AND HAD TO UNDERGO AN ANTI-INFECTION TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826606 LATEX FOLEY CATHETER FOLEY CATHETER EZC BARD SDN. BHD. -8040607 6EM9067

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention