PREMIER CERAPLUS DRAINABLE POUCH WITH CTF BARRIER

Additional Manufacturer Narrative

TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS FOR BARRIER ALLOWING LEAKAGE IDENTIFIED. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED BECAUSE LOT NUMBER WAS NOT PROVIDED. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF BARRIER ALLOWING LEAKAGE UNDER THE OSTOMY BARRIER CANNOT BE DETERMINED.

Description of Event or Problem

AN END USER REPORTED THAT A WEEK AFTER GETTING HER STOMA, THE HOLLISTER OSTOMY BARRIER THAT SHE WAS USING ALLOWED EFFLUENT LEAKING UNDER THE APPLIANCE AND SHE HAD TO CHANGE HER APPLIANCE OFTEN. SHE REPORTED THAT THE LEAKAGE IRRITATED HER SKIN AND REMOVING THE BARRIER IRRITATED IT FURTHER. SHE REPORTED THAT SHE WENT TO HER PRIMARY CARE PHYSICIAN ON MONDAY AND HE SAID THAT THE SKIN IRRITATION WAS A FUNGAL INFECTION. SHE REPORTED THAT THE DOCTOR PRESCRIBED NYSTATIN POWDER. SHE STATED HER STOMA DOES NOT PROTRUDE MUCH ABOVE HER SKIN LEVEL AND THE EFFLUENT CAN EASILY GET UNDER THE BARRIER. SHE REPORTED THAT THE BARRIER HAS NOW STAYED ON FOR ONE FULL DAY. HOLLISTER CUSTOMER SERVICE IS SENDING HER SOFT CONVEXITY TO TRY TO SEE IF THAT HELPS DIRECT THE EFFLUENT INTO THE POUCH BETTER.