NEW IMAGE BARRIER

Description of Event or Problem

IT WAS REPORTED THAT AN END USER'S HOLLISTER NEW IMAGE BARRIER WAS ONLY ADHERING 1-3 DAYS LEADING TO LEAKAGE, SKIN IRRITATION AND PAIN. IT WAS REPORTED HE WENT TO THE HOSPITAL FOR THE RASH AND PAIN, AND THEY PRESCRIBED A 5-DAY COURSE OF HIGH DOSE IBUPROFEN. IT WAS FURTHER REPORTED THAT OVER TIME, THE WEAR TIME AND SKIN IRRITATION HAS NOT IMPROVED AND SO NOW HE IS ON AN ANTIBIOTIC OINTMENT FOR THE SKIN.

Additional Manufacturer Narrative

TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. DEVICE HISTORY REVIEW CONDUCTED AND THE RECORDS WERE COMPLETE AND ACCURATE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED LEAKAGE AND IRRITATION UNDER THE OSTOMY BARRIER CANNOT BE DEFINITIVELY DETERMINED.