CONFORM 2 FLEXTEND SOFT CONVEX CUT TO FIT OSTOMY BARRIER

Additional Manufacturer Narrative

ALTHOUGH HOLLISTER DOES NOT SELL (B)(4) IN THE US, A SIMILAR OSTOMY BARRIER PRODUCT, (B)(4), IS SOLD IN THE US. TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED OVER THE LAST 3 YEARS. DEVICE HISTORY RECORDS (DHR) COULD NOT BE REVIEWED BECAUSE LOT NUMBER WAS NOT PROVIDED. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF THE SKIN REACTION TO THE HOLLISTER OSTOMY PRODUCT CANNOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT ABOUT ONE WEEK AFTER RADIATION THERAPY, AN END USER STARTED TO EXPERIENCE ITCHING AT THE STOMA UNDER THE HOLLISTER CONFORM 2 OSTOMY BARRIER. IT WAS REPORTED THAT THE ITCHING LEAD TO SKIN REDNESS AND OOZING WHICH SPREAD TO OTHER AREAS OF HIS BODY INCLUDING SKIN RIDGES & FOLDS AND THE EYES. IT WAS REPORTED THAT THE END USER WENT TO A DERMATOLOGIST WHO CONDUCTED ALLERGY TESTING WHICH SHOWED HE REACTED TO HOLLISTER PRODUCTS. IT WAS FURTHER REPORTED THAT HE WAS PRESCRIBED A MILKY TINCTURE TO TREAT THE AREAS. IT WAS REPORTED THAT THE AFFECTED AREAS HAVE NOW SCABBED OVER. IT WAS REPORTED THAT ACCORDING TO THE DOCTORS AT THE DERMATOLOGY CLINIC, IT'S DUE TO AN ALLERGIC REACTION THAT BLOSSOMED AFTER HIS IMMUNE SYSTEM REBOOTED AFTER RADIATION THERAPY.