BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PUREWICK URINE COLLECTION SYSTEM

    MDR report key: 23322436 · Received October 17, 2025

    Report

    Report Number
    1018233-2025-09253
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    October 7, 2025
    Report Date
    October 20, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    NZU
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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. 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 INITIAL REPORTER'S ZIP CODE: (B)(6). 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 NUMBER AND THE 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. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. CORRECTION: D. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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 THE PT COMPLAINED THAT MALE PW ADHESIVE IS TEARING PT'S SKIN. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. USED WITH MALE WICKS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. NO MEDICAL INTERVENTION WAS REPORTED PER ADDITIONAL INFORMATION, VIA PHONE ON 07OCT2025 IT WAS REPORTED T/S DONE AND STILL NOT WORKING PROPERLY, PROVIDED PHONE NUMBER FOR REFUND/EXCHANGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PT COMPLAINED THAT MALE PW ADHESIVE IS TEARING PT'S SKIN. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. USED WITH MALE WICKS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. NO MEDICAL INTERVENTION WAS REPORTED PER (B)(6), VIA PHONE ON 07OCT2025 IT WAS REPORTED T/S DONE AND STILL NOT WORKING PROPERLY, 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
    268058 UNKNOWN PUREWICK URINE COLLECTION SYSTEM PUREWICK NZU C.R. BARD INC. (COVINGTON) -1018233 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other