NEW IMAGE CONVEX FLEXTEND CUT TO FIT OSTOMY BARRIER

Additional Manufacturer Narrative

TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED OVER THE LAST 3 YEARS. LOT NUMBER PROVIDED. DEVICE HISTORY RECORDS REVIEWED AND FOUND TO BE COMPLETE AND ACCURATE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED SKIN IRRITATION, BLISTERS, AND REDNESS UNDER THE BARRIER AND BEYOND CANNOT BE DETERMINED. HOLLISTER IS SENDING SAMPLES OF A DIFFERENT HOLLISTER SKIN BARRIER FOR THE END USER TO TRY.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER EXPERIENCED PAIN AND REDNESS ON HER SKIN AFTER REMOVING HER HOLLISTER OSTOMY EXTENDED WEAR BARRIER THAT HAD ONLY BEEN IN PLACE FOR SEVERAL HOURS. SHE REPORTED THAT THE BARRIER WAS DIFFICULT TO REMOVE. SHE REPORTED THAT SHE APPLIED A NEW BARRIER BUT NEEDED TO REMOVE IT LATER THAT DAY BECAUSE HER SKIN WAS BURNING AND ITCHING. SHE REPORTED THAT AGAIN WAS DIFFICULT TO REMOVE AND WHEN SHE REMOVED THE BARRIER, THERE WERE BLISTERS AND REDNESS ON HER SKIN THAT EXTENDED BEYOND THE EDGES OF THE BARRIER. SHE REPORTED SHE WENT TO HER DOCTOR THE NEXT DAY WHO SAID SHE MAY BE EXPERIENCING AN ALLERGIC REACTION, ALTHOUGH NO ALLERGY TESTING WAS DONE. SHE REPORTED HE PRESCRIBED CLOTRIMAZOLE BETAMETHASONE (ANTIFUNGAL & CORTICOSTEROID) CREAM TO TREAT THE AFFECTED AREA. SHE SAID SHE IS SEEING SLIGHT IMPROVEMENT ALREADY. HOLLISTER IS SENDING DIFFERENT BARRIER PRODUCTS FOR HER TO TRY.