FDA Adverse Event Injury Summary report: N

DRAINABLE POUCH 25760 (COLOSTOMY BAGS)

MDR report key: 22213081 · Received June 16, 2025

Report

Report Number
MW5171500
Event Type
Injury
Date Received
June 16, 2025
Date of Event
February 13, 2025
Report Date
May 13, 2025
Manufacturer
HOLLISTER INCORPORATED
Product Code
EXE
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IN
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I AM USING HOLLISTER UROSTOMY PRODUCTS SINCE 2010 & COLOSTOMY PRODUCTS SINCE 2018. THE REQUIRED PRODUCTS ARE BOUGHT FROM HOLLISTER INC. INDIA DISTRIBUTOR (B)(4) OR THEIR DISTRIBUTOR (B)(4). PLEASE NOTE THE FOLLOWING: I'M A CANCER PATIENT SINCE 2008. DUE TO THE CANCER MY BLADDER WAS REMOVED IN 2010 & MY RECTUM IN 2018. I'VE BEEN USING HOLLISTER PRODUCTS FOR UROSTOMY (SINCE 2010) & HOLLISTER COLOSTOMY (2018) THROUGH THEIR INDIAN DISTRIBUTOR (B)(4). LN 2012 I WAS FACING A PROBLEM WITH THE UROSTOMY BAGS SO I COMPLAINED TO THE HOLLISTER DISTRIBUTOR WHO IMMEDIATELY STOPPED MY SUPPLY OF THE UROSTOMY BAGS AND BASES - I APPROACHED THE PARENT CO IN USA WHO IMMEDIATELY REFERRED THE ISSUE TO THEIR AREA REPRESENTATIVE (B)(4) WHO SETTLED THE ISSUE. NOW I AM FACING A PROBLEM WITH THE COLOSTOMY BAGS (THEY DO NOT RETAIN SMELL AND ALSO ARE LEAKING) (HOLLISTER IRELAND HAS ACCEPTED THE FACT THAT THERE IS A PROBLEM WITH THAT PARTICULAR BATCH AND THE BAGS WERE REPLACED). DUE TO MY COMPLAINT THE DISTRIBUTOR HAS STOPPED THE SUPPLY OF THESE PRODUCTS TO ME. HOLLISTER COS. REPRESENTATIVES ARE INCOMMUNICADO ON THE ISSUE OR GIVING VAGUE RESPONSES FOR THE NON-SUPPLY. THERE IS NO RESPONSE ON THIS ISSUE FROM THE PARENT CO (COMPANY) IN USA AS WELL. I REQUEST THAT THE CO (COMPANY) SHOULD BE SANCTIONED FOR THEIR REFUSAL FOR SUPPLYING LIFE SAVING MEDICAL PRODUCTS IMMEDIATELY. A QUALITY INSPECTION SHOULD BE CARRIED OUT AT THE HOLLISTER FACILITIES IMMEDIATELY & COMPENSATION GIVEN TO ME FOR TRAUMA CAUSED DUE TO NON-SUPPLY OF LIFESAVING MEDICAL DEVICES. REFERENCE REPORT #: MW5171501.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
987610 DRAINABLE POUCH 25760 (COLOSTOMY BAGS) PROTECTOR, OSTOMY EXE HOLLISTER INCORPORATED 25760 4B043

Patients

Seq Age Sex Outcome Treatment
1 63 YR Male Life Threatening CALCIUM. | CURCUMIN.| LOPERAMIDE (SOS).| MATIDA FORTE. | OSTEOCALCIUM.| SODAMINT.