PREMIER FLAT OSTOMY LNR POUCH WITH CUT TO FIT BARRIER

Additional Manufacturer Narrative

LOT NUMBER NOT PROVIDED SO DHR REVIEW NOT POSSIBLE. SAMPLE NOT RETURNED SO SAMPLE REVIEW NOT POSSIBLE. ROOT CAUSE OF REPORTED ULCERS AND BLISTERS UNDER THE OSTOMY APPLIANCE CANNOT BE INDEPENDENTLY CONFIRMED.

Description of Event or Problem

IT WAS REPORTED THAT THE END USER'S SUPPLIER COULD NOT SUPPLY HER USUAL HOLLISTER CONVEX OSTOMY BARRIER POUCHING SYSTEM SO THEY PROVIDED HER WITH A FLAT HOLLISTER OSTOMY POUCHING SYSTEM. THE END USER REPORTED THAT THIS HAD BEEN GOING ON FOR ABOUT 2 MONTHS. END USER REPORTED THAT SINCE HER STOMA WAS FLUSH TO THE SKIN, THIS ALLOWED EFFLUENT LEAKAGE UNDER THE BARRIER WHICH LED TO THE NEED FOR FREQUENT OSTOMY APPLIANCE CHANGES. END USER FURTHER REPORTED THAT THE FREQUENT CHANGES LEAD TO 4 SKIN ULCERS/BLISTERS UNDER THE BARRIER. END USER REPORTED THAT ONE BLISTER BROKE OPEN AND BLOOD AND PUS CAME OUT. SHE REPORTED THAT SHE WENT TO THE ED WHO PROVIDED HER A PASTE AND ORAL ANTIBIOTICS. HOLLISTER WILL PROVIDE SAMPLES OF HER CONVEX POUCHING SYSTEM TO TIDE HER OVER UNTIL SHE CAN GET THAT PRODUCT FROM HER SUPPLIER.