CERAPLUS PREMIER SOFT CONVEX DRAINABLE POUCH

Additional Manufacturer Narrative

TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. DEVICE HISTORY REVIEW CONDUCTED BASED ON LOT NUMBER PROVIDED AND RECORDS FOUND TO BE COMPLETE AND ACCURATE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED IRRITATION UNDER THE OSTOMY BARRIER CANNOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT AN OSTOMATE EXPERIENCED SKIN IRRITATION AND REDNESS UNDER THE HOLLISTER OSTOMY BARRIER DUE TO EFFLUENT LEAKAGE. IT WAS FURTHER REPORTED THAT PRESCRIPTIVE POWDER WAS REQUIRED TO ADDRESS THE SKIN IRRITATION AND REDNESS.