BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREWICK

    MDR report key: 23134918 · Received September 24, 2025

    Report

    Report Number
    1018233-2025-08542
    Event Type
    Injury
    Date Received
    September 24, 2025
    Date of Event
    September 17, 2025
    Report Date
    September 30, 2025
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    NZU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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 LABELING IS FOUND TO BE ADEQUATE. THE BAW IS ATTACHED ON THE INVESTIGATION OVERVIEW ELEMENT. THIS OCCURRENCE DOES NOT INTRODUCE A NEW HAZARD OR HARM. IT REPRESENTS A KNOWN FAILURE MODE THAT HAS BEEN ASSESSED IN THE PRODUCT RISK MANAGEMENT FILE IN ACCORDANCE WITH APPLICABLE REGULATORY STANDARDS AND INTERNAL PROCEDURES. THE ASSOCIATED RISKS CONTINUE TO BE MONITORED AS PART OF ONGOING POST-MARKET ACTIVITIES IN COMPLIANCE WITH BOTH REGULATORY REQUIREMENTS AND LOCAL PROCEDURES. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. CORRECTION: D. 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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

    IT WAS REPORTED THAT PATIENT STATED THEY HAD BEEN IN TALKS WITH INFECTIOUS DISEASE DOCTOR AND HAD STOPPED USE. THEN HUNG UP. IT IS UNCLEAR IF LOT NUMBER WAS REQUESTED. USED WITH FLEX WICKS. NO ADDITIONAL INFORMATION PROVIDED. NO TROUBLESHOOTING WAS PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION PROVIDED FOR INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT STATED THEY HAD BEEN IN TALKS WITH INFECTIOUS DISEASE DOCTOR AND HAD STOPPED USE. THEN HUNG UP. IT IS UNCLEAR IF LOT NUMBER WAS REQUESTED. USED WITH FLEX WICKS. NO ADDITIONAL INFORMATION PROVIDED. NO TROUBLESHOOTING WAS PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION PROVIDED FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851034 PUREWICK PUREWICK FLEX FEMALE EXTERNAL CATHETER NZU C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other