BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD PUREWICK MALE EXTERNAL CATHETER

    MDR report key: 21067881 · Received January 2, 2025

    Report

    Report Number
    MW5164236
    Event Type
    Death
    Date Received
    January 2, 2025
    Date of Event
    November 21, 2024
    Report Date
    December 30, 2024
    Manufacturer
    BD/C.R. BARD, INC.
    Product Code
    NZU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HELLO, MY HUSBAND CONTRACTED A MALE YEAST INFECTION THAT WENT SEPTIC AFTER USING THE "MALE EXTERNAL BD PUREWICK CATHETER". AT THE TIME HE WAS MEDICALLY FRAGILE AND HE DIED ON (B)(6) 2024 FROM LIVER AND KIDNEY FAILURE CAUSED PRIMARILY BY THE TOXIC ANTIFUNGALS GIVEN TO HIM TO TREAT THAT SEPTIC INFECTION. THE PRODUCT IS SUPPOSED TO WICK AWAY URINE AND IS SUPPOSED TO BE SUCTIONED INTO A VACUUM BOTTLE. WE HAD A GREAT EXPERIENCE WITH THE FEMALE CATHETER AND HOPED THE MALE VERSION WOULD BE EVEN BETTER. INSTEAD, THE MALE VERSION KEPT URINE ON MY HUSBAND'S SKIN OVERNIGHT AND WE WERE AT THE EMERGENCY ROOM WITHIN 24 HRS WITH A UTI (URINARY TRACT INFECTION) THAT TURNED SEPTIC. THE TESTS SHOWED CANDIDIASIS AS THE MAIN PROBLEM, AND HE WAS SUBSEQUENTLY TREATED WITH STRONG ANTIFUNGAL MEDS THAT BASICALLY OVERWHELMED HIS LIVER AND KIDNEYS. HE DIED ON (B)(6) 2024 OF LIVER AND KIDNEY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639381 BD PUREWICK MALE EXTERNAL CATHETER COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER NZU BD/C.R. BARD, INC. PWMX30 NGJU399

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| D