HOLLISTER CERAPLUS OSTOMY BARRIER

Description of Event or Problem

IT WAS REPORTED THAT AN END USER DEVELOPED IRRITATION WITH WEEPING AND BLISTERS UNDER THE TAPE BORDER OF THE HOLLISTER OSTOMY BARRIER 5 MONTHS AFTER HE FIRST STARTED USING THE PRODUCT. IT WAS FURTHER REPORTED THAT DESPITE USING STOMA POWDER AND SKIN PREP, THE IRRITATION CONTINUED. IT WAS REPORTED HE WENT TO SEE HIS HEALTH CARE PROFESSIONAL WHO PRESCRIBED CLOBETASOL CREAM TO BE USED TWICE A WEEK AND THE AREA IS NOW IMPROVING.

Additional Manufacturer Narrative

TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED BECAUSE LOT NUMBER NOT PROVIDED. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED IRRITATION UNDER THE OSTOMY TAPE BORDER CANNOT BE DETERMINED. ONLY THE DI IS AVAILABLE FOR THE UDI SINCE THE LOT NUMBER WAS NOT PROVIDED.