BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUREWICK INCONTENANCE PRODUCT

    MDR report key: 21056877 · Received January 2, 2025

    Report

    Report Number
    MW5164149
    Event Type
    Death
    Date Received
    January 2, 2025
    Date of Event
    August 24, 2024
    Report Date
    December 28, 2024
    Manufacturer
    C. R. BARD, INC.
    Product Code
    NZU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WELL ADMITTED TO (B)(6). THE MEDICAL STAFF USED THE PURE WICK AT HOME INCONTINENCE PRODUCT ON MY MOTHER, (B)(6) WITHOUT CONCERN FOR HARM OR INJURY TO HER. AFTER LETHARGIC AND BEDRIDDEN FOR FOUR DAYS WHEN THE PRODUCT RULES REMOVED, IT CAUSED SEVERE TRAUMA TO THE SKIN. IT CONTINUED FOR YEARS THROUGH WOUND EXPERT TREATMENT AND EVENTUALLY DEVELOPED INTO CANCER. FOLLOWED BY MANY MONTHS OF TREATMENT, FETAL INCONTINENCE AND BLEEDING TO THE POINT OF ALMOST HEMORRHAGING.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 1/6/2024 FOR REPORT MW5164149 TO UPDATE THE MANUFACTURER TO C.R. BARD, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375050 PUREWICK INCONTENANCE PRODUCT COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER NZU C. R. BARD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 102 YR Female Required Intervention| L| D