NEW IMAGE FLEXTEND CUT TO FIT OSTOMY BARRIER

Additional Manufacturer Narrative

TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED OVER THE LAST 3 YEARS. END USER SAID THIS IS NOT A LOT-SPECIFIC PROBLEM. SINCE LOT NUMBER NOT PROVIDED DHR REVIEW NOT POSSIBLE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. PATIENT'S RACE IS NOT KNOWN. ROOT CAUSE OF REPORTED SKIN IRRITATION AND ITCHING UNDER THE BARRIER CANNOT BE DETERMINED. HOLLISTER IS SENDING SAMPLES OF A DIFFERENT STYLE OF HOLLISTER SKIN BARRIERS (CONVEX) FOR THE END USER TO TRY IN ORDER TO ADDRESS THE REPORT OF EFFLUENT LEAKAGE UNDER THE BARRIER.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER WHO HAS BEEN USING THE HOLLISTER NEW IMAGE BARRIER STARTED EXPERIENCING IRRITATED, ITCHY AND DISCOLORED SKIN UNDER HER BARRIER IN OCTOBER. SHE WAS PRESCRIBED NYSTATIN POWDER AND IT CLEARED UP. SHE STARTED EXPERIENCING THE SAME THING RECENTLY ASSOCIATED WITH EFFLUENT LEAKAGE UNDER THE BARRIER. SHE HAS BEEN NEEDING TO CHANGE THE BARRIER MORE OFTEN BECAUSE OF THE LEAKAGE WHICH IS CAUSING SOME AREAS UNDER THE BARRIER TO BLEED. SHE AGAIN STARTED USING NYSTATIN POWDER AND THE SKIN IS IMPROVING.