NEW IMAGE CONVEX CERAPLUS TAPE BORDERED PRESIZED BARRIER

Description of Event or Problem

THE END USER REPORTED THAT SHE EXPERIENCED IRRITATION UNDER THE BARRIER, THE TAPE BORDER AND BEYOND THE EDGES OF THE HOLLISTER NEW IMAGE BARRIER A LITTLE OVER TWO WEEKS AGO. SHE REPORTED SHE SAW HER DERMATOLOGIST WHO SAID IT WAS CONTACT DERMATITIS AND PRESCRIBED A CREAM. SHE DESCRIBES HER SKIN AS BEING OOZY, RED, BLEEDING, ITCHING, BURNING AND STICKY. SHE SAID SHE USED THE PRESCRIBED CLOBETASOL PROPIONATE CREAM FOR JUST UNDER TWO WEEKS AND SINCE HER SKIN WAS GETTING BETTER, SHE STOPPED USING IT. SHE SAID THE SKIN IRRITATION CAME BACK WHEN SHE STOPPED USING IT. SHE REPORTED HER DOCTOR INSTRUCTED HER TO USE THE CREAM AGAIN BUT THIS TIME FOR THE FULL TWO WEEKS.

Additional Manufacturer Narrative

TREND ANALYSIS CONDUCTED FOR DEVICE CAUSING SKIN IRRITATION FOR THIS SKU AND NO ADVERSE TRENDS OBSERVED. DEVICE HISTORY RECORD (DHR) REVIEW CONDUCTED, AND THE RECORDS WERE FOUND TO BE COMPLETE AND ACCURATE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED SKIN IRRITATION UNDER THE OSTOMY APPLIANCE CANNOT BE DETERMINED.