NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER

Additional Manufacturer Narrative

TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. LOT NUMBER NOT PROVIDED SO DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED IRRITATION UNDER THE OSTOMY BARRIER AND TAPE BORDER CANNOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER DEVELOPED SKIN IRRITATION UNDER THE HOLLISTER NEW IMAGE OSTOMY BARRIER APPROXIMATELY 1 ½ YEARS AGO. SHE WAS TOLD IT WAS A YEAST INFECTION WHICH BECAME SEPTIC AND SHE WAS HOSPITALIZED. SHE REPORTED THAT THE SKIN IRRITATION HAS NEVER GONE AWAY FULLY. SHE REPORTS NOW HAVING BLISTERS ON THE SKIN AND IT IS VERY ITCHY. SHE STATES THIS IS UNDER BOTH THE BARRIER AND THE TAPE BORDER OF THE BARRIER. SHE REPORTS SHE WAS PRESCRIBED MICONAZOLE WHICH DID NOT WORK FULLY SO SHE WAS RECENTLY PRESCRIBED BETAMETHASONE AND CLOTRIMAZOLE OINTMENT. SHE REPORTS THAT IS HELPING. SHE REPORTS HAVING AN ALLERGY TO ADHESIVES. HOLLISTER CUSTOMER SERVICE IS SENDING HER SAMPLES OF CERAPLUS BARRIERS FOR HER TO TRY.