BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREWICK MALE EXTERNAL CATHETER

    MDR report key: 23425393 · Received October 30, 2025

    Report

    Report Number
    1018233-2025-09731
    Event Type
    Injury
    Date Received
    October 30, 2025
    Date of Event
    October 23, 2025
    Report Date
    November 7, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741226465
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 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. THE REPORTED EVENT IS ADDRESSED WITHIN THE LABELING. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. 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

    CRITICAL CARE NURSE STATED THAT WHEN FILLING OUT AN ONLINE SURVEY, THE CAREGIVER (ID: (B)(6)) INDICATED THAT THE PATIENT THEY CARE FOR EXPERIENCED SKIN IRRITATION/INFLAMMATION (NO BROKEN SKIN) AND A URINARY TRACT INFECTION AFTER USING THE PUREWICK SYSTEM FOR MEN IN THE PAST 3 MONTHS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CRITICAL CARE NURSE STATED THAT WHEN FILLING OUT AN ONLINE SURVEY, THE CAREGIVER (ID: (B)(6)) INDICATED THAT THE PATIENT THEY CARE FOR EXPERIENCED SKIN IRRITATION/INFLAMMATION (NO BROKEN SKIN) AND A URINARY TRACT INFECTION AFTER USING THE PUREWICK SYSTEM FOR MEN IN THE PAST 3 MONTHS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2380875 PUREWICK MALE EXTERNAL CATHETER PUREWICK MALE EXTERNAL CATHETER NZU C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741226465

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other