BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN PUREWICK FEMALE EXTERNAL CATHETER

    MDR report key: 24650669 · Received March 20, 2026

    Report

    Report Number
    1018233-2026-01916
    Event Type
    Death
    Date Received
    March 20, 2026
    Date of Event
    March 6, 2026
    Report Date
    March 23, 2026
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    NZU
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. A LABELING REVIEW COULD NOT BE PERFORMED SINCE NO MATERIAL NUMBER WAS PROVIDED. A DHR REVIEW IS NOT REQUIRED AS THE LOT NUMBER IS UNKNOWN. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. 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 THAT THE CUSTOMERS MOTHER WAS USING PUREWICK FEMALE EXTERNAL CATHETER FOR 3 MONTHS WHILE IN THE HOSPITAL, STAFF DID NOT PLACE THE CATHETER PROPERLY RESULTED IN HER BED WAS ALWAYS WET AND BLAMED CUSTOMERS MOTHER WAS MOVING AROUND. CUSTOMER NOW HAD A HUGE BLACK INFECTED BED SORE. AND IT BECAME DEEPER MORE INFECTED AND SHE TURNED SEPTIC AND PASSED AWAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER'S MOTHER WAS USING PUREWICK FEMALE EXTERNAL CATHETER FOR 3 MONTHS WHILE IN THE HOSPITAL, STAFF DID NOT PLACE THE CATHETER PROPERLY RESULTED IN HER BED WAS ALWAYS WET AND BLAMED CUSTOMER'S MOTHER WAS MOVING AROUND. CUSTOMER NOW HAD A HUGE BLACK INFECTED BED SORE. AND IT BECAME DEEPER MORE INFECTED AND SHE TURNED SEPTIC AND PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134550 UNKNOWN PUREWICK FEMALE EXTERNAL CATHETER UNKNOWN PUREWICK FEMALE EXTERNAL CATHETER NZU C.R. BARD INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1