BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTOMY DRAINABLE POUCH

    MDR report key: 22728327 · Received August 6, 2025

    Report

    Report Number
    MW5174102
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    June 29, 2025
    Report Date
    July 17, 2025
    Manufacturer
    HOLLISTER, INC.
    Product Code
    EXB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE A UROSTOMY SINCE 2010. I'M USING HOLLISTER UROSTOMY POUCHES AND BASES. IN THE CURRENT LOT 48133 OF DRAINABLE POUCHES THE BAG COLOUR CHANGED TO PURPLE AFTER 3 USAGES. WHEN I PUT THE PROBLEM TO THE DISTRIBUTOR OF HOLLISTER (S-THREE SALES INTL. PVT., LTD.) I WAS INFORMED THAT SUCH AN OCCURRENCE CAN HAPPEN AS A "SI" ALKALINE URINARY TRACT INFECTION. I GOT MY URINE TEST DONE WHICH CAME BACK AS NORMAL I AM STILL WAITING FOR A REPLY FROM THE DISTRIBUTOR / HOLLISTER CO., AS TO WHY THE "PURPLE BAG SYNDROME" HAS OCCURRED EVEN WHEN THERE IS NO UTI. THE NEW AND DEFECTIVE BAGS ARE WITH ME IF REQUIRED FOR EVALUATION. THE DISTRIBUTOR HAS STOPPED MY SUPPLY OF UROSTOMY AND COLOSTOMY PRODUCTS AS I HAVE MADE A COMPLAINT REGARDING THE PRODUCTS. (EARLIER COMPLAINT REGARDING LEAKAGE FROM COLOSTOMY BAGS IS PENDING WITH FDA). IS THE HOLLISTER CO. JUSTIFIED IN STOPPING SUPPLY, OF LIFE SAVING MEDICAL DEVICES, SIMPLY BECAUSE A COMPLAINT HAS BEEN MADE AGAINST THE PRODUCT. THE HOLLISTER CO. SHOULD BE MADE MONETARILY LIABLE FOR CAUSING THE PATIENT MENTAL TRAUMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501793 OSTOMY DRAINABLE POUCH COLLECTOR, OSTOMY EXB HOLLISTER, INC. 25830 48133

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other CALCIUM. | COLOSTOMY.| CURCUMIN. | LOMOFEN/LOPERAMIDE.| MALILDA FORTE. | SODA MINT.