OSTOMY DRAINABLE POUCH
Received Aug 6, 2025 · Event occurred Jun 29, 2025
Report MW5174102 · MDR key 22728327
Device
Product problems
- Defective Device
- Patient Device Interaction Problem
Patient
63 YR · Male
- Unspecified Mental, Emotional or Behavioural Problem
- Unspecified Mental, Emotional or Behavioural Problem
Narrative
Description of Event or Problem
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.