BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PUREWICK FEMALE EXTERNAL CATHETER

    MDR report key: 23116308 · Received September 22, 2025

    Report

    Report Number
    1018233-2025-08448
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    August 23, 2025
    Report Date
    December 18, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    NZU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. A LABELING REVIEW COULD NOT BE PERFORMED SINCE NO PRODUCT CATALOG NUMBER AND THE LOT NUMBER WAS PROVIDED. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: D. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT PATIENT PASSED AWAY FROM UTI CAUSED SEPSIS, AND CUSTOMER WONDERS IF PUREWICK FEC CAUSED THAT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT PATIENT PASSED AWAY FROM UTI CAUSED SEPSIS, AND CUSTOMER WONDERS IF PUREWICK FEC CAUSED THAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542540 UNKNOWN PUREWICK FEMALE EXTERNAL CATHETER PUREWICK FEMALE CATHETER NZU C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other