CONFORM 2 CONVEX CUT TO FIT TAPE BORDERED BARRIER

Additional Manufacturer Narrative

PATIENT'S WEIGHT NOT KNOWN SO ESTIMATE USED. NO LOT NUMBER OR SAMPLES PROVIDED SO DHR REVIEW AND SAMPLE EVALUATION IS NOT POSSIBLE. A REVIEW OF HOLLISTER'S POST MARKET COMPLAINT DATABASE SHOWS NO OTHER COMPLAINTS OF SKIN IRRITATION FOR THIS PRODUCT OVER THE LAST 3 YEARS. A REVIEW OF THE PRODUCT RISK ASSESSMENT SHOWS THAT THE HARM OF SKIN IRRITATION ASSOCIATED WITH THE USE OF HOLLISTER'S BARRIER PRODUCTS IS PRESENT THE RISKS ARE BEING REDUCED TO THE EXTENT POSSIBLE AND THIS CONCLUSION REMAINS UNCHANGED. THE ROOT CAUSE OF THE REPORTED SKIN IRRITATION CANNOT BE DETERMINED. HOLLISTER WILL CONTINUE TO TRACK AND TREND THE PERFORMANCE OF THE BARRIER IN OUR POST MARKET COMPLAINT SYSTEM.

Description of Event or Problem

THIS REPORT IS FOR THE THIRD OF SEVEN PATIENTS REPORTED THROUGH THE SAME DISTRIBUTOR WHO EXPERIENCED SKIN IRRITATION. IT WAS REPORTED THAT AN END USER EXPERIENCED SKIN IRRITATION UNDER THE HOLLISTER OSTOMY BARRIER. THE IRRITATION BEGAN 17 DAYS WEEKS AFTER THEY STARTED USING THE BARRIER. THE PATIENT SAW AN OSTOMY NURSE AND THEIR FAMILY PHYSICIAN WHO PRESCRIBED DERMACOMBIN (WHICH IS A COMBINATION OF NEOMYCIN SULFATE, GRAMICIDIN, NYSTATIN AND TRIAMCINOLONE ACETONIDE CREAM), PITRION (MICONAZOLE NITRATE 2%) AND ANTI-ALLERGY PILLS. THIS IS SUSPECTED TO BE AN ALLERGIC REACTION OR FUNGAL INFECTION. THE IRRITATION HAS NOT YET IMPROVED.