BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK MALE EXTERNAL CATHETER

    MDR report key: 24758364 · Received April 1, 2026

    Report

    Report Number
    1018233-2026-02147
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    February 12, 2026
    Report Date
    March 30, 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: PRECAUTIONS: NOT RECOMMENDED FOR USERS WHO ARE AGITATED, COMBATIVE, OR UNCOOPERATIVE AND MIGHT REMOVE THE DEVICE. HAVE FREQUENT EPISODES OF BOWEL INCONTINENCE WITHOUT A FECAL MANAGEMENT SYSTEM IN PLACE. HAVE SKIN IRRITATION OR BREAKDOWN AT THE SITE. 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. PROCEED WITH CAUTION IN USERS WHO HAVE HAD RECENT SURGERY OF THE EXTERNAL MALE ANATOMY. ALWAYS CHECK SKIN FOR IRRITATION OR BREAKDOWN AND CLEAN AND DRY THE SKIN PRIOR TO PLACEMENT OF A NEW DEVICE. 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 A REGISTERED NURSE SPOKE TO THE SON WHO PURCHASED DEVICE FOR HIS FATHER. HIS FATHER COMPLAINED OF A BURNING SENSATION. ON THE TOP PART OF THE MALE WICK, AROUND TOP VENT AREA. CLIENT HAD BEEN NEARING THE 24 HOUR MARK WITH HIS WICK. IT ALSO LOOKED DISCOLORED. THE SON WAS WONDERING HOW PEE COULD GET THERE. REGISTERED NURSE CLARIFIED DUE TO HIM UNABLE TO HOLD HIS PENIS AND DIRECT IT DOWNWARDS SOMETIMES IT CAN MOVE AND LAND SOMEWHERE ELSE. CLIENT WAS ALSO WORRIED ABOUT THE SWEAT ON HIS BACK FROM LAYING ALL NIGHT. REGISTERED NURSE ENCOURAGED TO USE BLUE PADS UNDERNEATH AND ENSURING HE IS GETTING TURNED. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. IT IS UNKNOWN IF LOT OR SERIAL NUMBER WAS REQUESTED. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 05MAR2026,IT WAS REPORTED HE WAS PRESCRIBED ANTIBIOTICS DUE TO THE BURNING SENSATION IN HIS PENIS. IT WAS BELIEVED TO BE AN UTI. THE SON ALSO STATED THAT HE NOTICED THAT URINE WAS POOLING IN THE MALE WICK. I REFERRED HIM TO LMS FOR TROUBLESHOOTING TO MAKE SURE THAT THE UNIT IS SUCTIONING PROPERLY. HE WILL HAVE HIS FATHER'S CAREGIVER TO CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111852 PUREWICK MALE EXTERNAL CATHETER PUREWICK NZU C.R. BARD INC. (COVINGTON) -1018233 UNK 00801741226465

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other