BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDIA 30CC SILICONE-COATED LATEX FOLEY CATHETER

    MDR report key: 5039681 · Received August 28, 2015

    Report

    Report Number
    1018233-2015-00321
    Event Type
    Injury
    Date Received
    August 28, 2015
    Report Date
    February 29, 2016
    Manufacturer
    BARD SDN. BHD. -8040607
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    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 CONTAINS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A RASH FROM THE CATHETER. THE PATIENT ALLEGED THAT HE HAD TO VISIT 3 DERMATOLOGISTS, WHICH PRESCRIBED THE PATIENT CREAMS FOR THE RASH. THE PATIENT HAS THE CATHETER CHANGED EVERY 3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572043 BARDIA 30CC SILICONE-COATED LATEX FOLEY CATHETER FOLEY CATHETER EZC BARD SDN. BHD. -8040607 MYYCR182

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention