CERAPLUS ONE-PIECE SOFT CONVEX POUCH

Additional Manufacturer Narrative

TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. DEVICE HISTORY REVIEW CONDUCTED BASED ON LOT NUMBER PROVIDED AND RECORDS FOUND TO BE COMPLETE AND ACCURATE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED IRRITATION, REDNESS AND ITCHING UNDER THE OSTOMY BARRIER CANNOT BE DETERMINED. THIS EXACT PRODUCT IS NOT SOLD IN THE US BUT A SIMILAR PRODUCT, PREMIER CERAPLUS SOFT CONVEX LOCK N ROLL OSTOMY APPLIANCE IS.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER WAS REACTING TO THE HOLLISTER MODERMAFLEX OSTOMY BARRIER. IT WAS FURTHER REPORTED THAT THE SKIN WAS IRRITATED, WAS RED AND ITCHING WHERE THE BARRIER WAS APPLIED TO THE SKIN. ADDITIONALLY, IT WAS REPORTED THAT THE ITCHING SUBSIDED A FEW MINUTES AFTER THE BARRIER WAS REMOVED. IT WAS REPORTED THAT WHEN THE REDNESS OCCURRED, IT WAS SOMETIMES SO SEVERE THAT IT REQUIRED DERMATOLOGICAL TREATMENT WITH THE USE OF PRESCRIPTIVE CORTISONE.