BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PUREWICK FLEX FEMALE EXTERNAL CATHETER

    MDR report key: 23266003 · Received October 10, 2025

    Report

    Report Number
    1018233-2025-08978
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 13, 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 REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS, AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE PRODUCT CATALOG AND LOT NUMBER FOR THIS DEVICE ARE UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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 INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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 THAT THE HOSPITAL USER REPORTS, THE PATIENT CONTRACTED A UTI AND A YEAST INFECTION AFTER USING THE PUREWICK FEC. ALSO MENTIONED THEY HATED IT AND CAN'T MOVE AROUND OR SLEEP ON THE SIDE. ASKED TO PROVIDE AN OLD FASHIONED CATHETER NEXT TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HOSPITAL USER REPORTS, THE PATIENT CONTRACTED A UTI AND A YEAST INFECTION AFTER USING THE PUREWICK FEC. ALSO MENTIONED HATED IT AND CAN'T MOVE AROUND OR SLEEP ON THE SIDE. ASKED TO PROVIDE AN OLD FASHIONED CATHETER NEXT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112510 UNKNOWN PUREWICK FLEX FEMALE EXTERNAL CATHETER PUREWICK FEMALE CATHETER NZU C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other