BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREWICK FEMALE EXTERNAL CATHETER

    MDR report key: 23078925 · Received September 17, 2025

    Report

    Report Number
    1018233-2025-08268
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    September 12, 2025
    Report Date
    December 18, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741226984
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. ALL AVAILABLE UDI INFORMATION IS BEING PROVIDED. 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 IS NOT REQUIRED BECAUSE LABELING COULD NOT HAVE PREVENTED THE REPORTED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTIONS: B, D, F, H. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS 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

    AUTH SAID THE WICKS ARE DEFECTIVE AND PATIENT IS GETTING UTIS. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WICKS ARE DEFECTIVE AND PATIENT IS GETTING UTIS. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED. PER, VIA PHONE ON 30SEPT2025 IT WAS REPORTED, T/S DONE, BUT STILL UPSET WITH A BOX AND HALF OF DEFECTIVE WICKS, ADVISED TO ASK FOR REPLACEMENT WICKS FOR DEFECTIVE WICKS, PROVIDED 800-754-5919 REFUND/EXCHANGE M-F 9-8 AND SAT 9-3 EST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2597672 PUREWICK FEMALE EXTERNAL CATHETER PUREWICK NZU C.R. BARD INC. (COVINGTON) -1018233 MYHU3882 00801741226984

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other