BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK MALE EXTERNAL CATHETER

    MDR report key: 24388490 · Received February 19, 2026

    Report

    Report Number
    1018233-2026-00983
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    November 4, 2025
    Report Date
    February 13, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741226465
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 REPORTED EVENT IS ADDRESSED WITHIN THE LABELING AS IT STATES: WARNINGS: DO NOT USE ON IRRITATED SKIN. EXAMPLES INCLUDE, BUT ARE NOT LIMITED TO, RASHES, SKIN TEARS, OR BLISTERS. PRECAUTIONS: DO NOT USE BARRIER CREAMS, LOTIONS, OR OINTMENTS ON THE PENIS OR PUBIC SKIN AROUND THE BASE OF THE PENIS WHEN USING THE DEVICE. THESE MAY IMPEDE SUCTION OR WEAKEN ADHESIVE. RECOMMENDATIONS: WASH HANDS THOROUGHLY BEFORE DEVICE PLACEMENT. ENSURE THE DEVICE REMAINS CONNECTED AFTER TURNING THE USER, MONITORING FOR PULLING AND TENSION ON THE DEVICE. REMOVE THE DEVICE PRIOR TO WALKING. CHECK DEVICE PLACEMENT AND USER¿S SKIN AT LEAST EVERY 2 HOURS. PLACEMENT OF PUREWICK MALE EXTERNAL CATHETER - TRIM OR CLIP THE PUBIC HAIR TO ENSURE THE PRODUCT SECURELY ADHERES TO THE SKIN. CHECK THE SKIN AND DO NOT USE IF THERE IS IRRITATION OR BREAKDOWN. CLEAN THE PENIS AND THE SKIN AROUND THE BASE OF THE PENIS WITH SOAP AND WATER OR SOAP AND WATER WIPES. DRY SKIN PRIOR TO POSITIONING THE DEVICE. NOTE: MOISTURE OR SOAP RESIDUE ON SKIN WILL WEAKEN THE ADHESIVE. - POSITION THE DEVICE, ALIGNING DRAINAGE FITTING TOWARDS THE FEET OF THE USER. SLIDE THE OPENING OF THE DEVICE OVER THE PENIS UNTIL CLOSE TO, BUT NOT TOUCHING, THE SKIN AROUND THE BASE OF THE PENIS. CENTER PENIS WITHIN THE OPENING. DO NOT PLACE SCROTUM INSIDE THE DEVICE. REMOVE THE BOTTOM ADHESIVE PEEL OFF AND PRESS THE DEVICE AGAINST THE SKIN BELOW THE BASE OF THE PENIS. REMOVE THE TOP ADHESIVE PEE LOFF AND PRESS THE DEVICE AGAINST THE SKIN ABOVE THE BASE OF THE PENIS. ENSURE DEVICE HAS FULLY ADHERED AROUND THE BASE OF THE PENIS BY PRESSING DOWN ON THE ADHESIVE. WHEN TO REPLACE PUREWICK MALE EXTERNAL CATHETER - REPLACE THE DEVICE AT LEAST EVERY 24 HOURS OR IF SOILED WITH FECES, BLOOD, OR SEMEN. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. 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

    IT WAS REPORTED THAT THERE WAS AN ISSUE/COMPLAINT: DEVICE BAG FILLING UP WITH URINE/SUCTION ISSUE. ISSUE RESOLVED BY TROUBLESHOOTING. SPOKE TO CAREGIVER ABOUT CONNECTING COLLECTOR TUBING AFTER WICK HAS BEEN PLACED. WE ALSO TALKED ABOUT MAKING SURE THERE ARE NO CREASES IN DEVICE/BAG, MAKING SURE THE WHITE WICKING MATERIAL GOES FROM THE TOP OF DEVICE TO BLUE PORT. ALSO ENCOURAGED CAREGIVER TO ENSURE COLLECTOR TUBING IS NOT TWISTED OR COILED TOO MUCH AND REMINDED CAREGIVER TO KEEP VENT HOLES FREE OF BEING COVERED. CAREGIVER ACKNOWLEDGED, STATING SHE BELIEVES USER KEEPS MOVING TOO MUCH. SCHEDULED FOLLOW UP CALL (B)(6) 2025 2:00 PM CT. NO ADDITIONAL INFORMATION PROVIDED. NO TROUBLESHOOTING WAS PROVIDED. (PREPPING AND PLACEMENT TIPS SHARED). PER CUSTOMER, VIA PHONE ON (B)(6) 2026 IT WAS REPORTED TS DONE, PROVIDED 800-754-5919 REFUND/EXCHANGE M-F 9-8 AND SAT 9-3 EST NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122009 PUREWICK MALE EXTERNAL CATHETER PUREWICK NZU C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741226465

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other