PREMIER

Additional Manufacturer Narrative

A LOT NUMBER WAS NOT PROVIDED SO THE DEVICE HISTORY RECORDS WERE NOT ABLE TO BE REVIEWED. NO SAMPLES WERE AVAILABLE FOR RETURN SO DEVICE EXAMINATION NOT POSSIBLE. COMPLAINT DATA REVIEW WAS CONDUCTED, AND NO ADVERSE TRENDS OBSERVED. THE ROOT CAUSE OF THE REPORTED SKIN IRRITATION COULD NOT BE DETERMINED. CAUSATION HAS NOT BEEN ESTABLISHED. SINCE A LOT NUMBER WAS NOT PROVIDED, ONLY GUDID DI INFORMATION IS AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER HAS BEEN EXPERIENCING IRRITATED SKIN UNDER THE HOLLISTER OSTOMY BARRIER SINCE MARCH OF THIS YEAR. IT WAS REPORTED THAT THE PERISTOMAL SKIN IS ITCHY, RED AND BUMPY. IT WAS FURTHER REPORTED THAT THE IRRITATED SKIN CONTINUED DESPITE USING DIFFERENT TYPES OF OSTOMY BARRIERS OVER A PERIOD OF TIME. IT WAS FURTHER REPORTED THAT HE WAS PRESCRIBED CLOBETASOL PROPIONATE CREAM TO BE USED ON HIS IRRITATED SKIN UNDER THE APPLIANCE FOR TWO WEEKS.