NEW IMAGE BARRIER

Additional Manufacturer Narrative

TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED DUE TO NO LOT NUMBER PROVIDED. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED LEAKAGE AND IRRITATION UNDER THE OSTOMY BARRIER CANNOT BE DEFINITIVELY DETERMINED. ONLY THE DI FOR THE UDI IS AVAILABLE DUE TO LACK OF LOT NUMBER INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER HAD BEEN USING SEVERAL HOLLISTER OSTOMY BARRIERS A DAY AFTER SHE LOST 60 POUNDS AND THERE WAS A LOT OF LOOSE SKIN. IT WAS FURTHER REPORTED THAT SHE WAS EXPERIENCING BARRIER LEAKAGE ON THE BOTTOM OR LEFT SIDE AND HAD IRRITATION WITH FUNGAL AND YEAST INFECTIONS. IT WAS ADDITIONALLY REPORTED THAT SHE HAS BEEN USING PREDNISONE CREAM PER HER DOCTOR WHICH IS NOT ALLOWING HER BARRIER TO ADHERE TO THE SKIN. HOLLISTER PROVIDED SUGGESTIONS TO END USER.