MODERMA FLEX SOFT CONVEX CERAPLUS TAPE BORDERED UROSTOMY POUCH

Additional Manufacturer Narrative

THIS PRODUCT SKU, 59825, IS NOT SOLD IN THE US BUT IS EQUIVALENT TO 8414, PREMIER ONE-PIECE UROSTOMY POUCH WHICH IS SOLD IN THE US. A DHR REVIEW COULD NOT BE COMPLETED BECAUSE THE LOT NUMBER WAS NOT KNOWN. SAMPLE NOT RETURNED SO SAMPLE EVALUATION IS NOT POSSIBLE. TREND ANALYSIS WAS CONDUCTED FOR TAPE CAUSING SKIN IRRITATION FOR BOTH 59825 AND 8414 AND NO ADVERSE TRENDS OBSERVED. THE ROOT CAUSE OF THE END USER'S SKIN REACTION TO THE APPLIANCE IS NOT KNOWN.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER STARTED EXPERIENCING A SKIN REACTION TO THE TAPE BORDER OF THE HOLLISTER OSTOMY BARRIER. AT FIRST WHEN THE END USER EXPERIENCED SORE SKIN UNDER THE PRODUCT SHE THOUGHT HER STOMA SIZE MAY HAVE CHANGED. THE SORE SKIN EXTENDED UNDER THE BARRIER PORTION AS WELL AS AN ULCER SO SHE WAS PRESCRIBED A STEROID AND ANTIBIOTIC CREAM. THE END USER CONTINUES TO EXPERIENCE RED SKIN BUT THE ULCER HAS ALMOST FULLY HEALED AND THERE IS NO MORE PAIN. IT WAS SUGGESTED THAT SHE HAVE HER OSTOMY APPLIANCE SWAPPED OUT FOR AN ALTERNATIVE PRODUCT.