NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER 1" PS

Additional Manufacturer Narrative

BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. LOT NUMBER NOT PROVIDED SO DHR REVIEW NOT POSSIBLE. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. THE ROOT CAUSE OF THE SKIN IRRITATION CANNOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT END USER DEVELOPED AN ERYTHEMATOUS RED RASH UNDER THE TAPE BORDER OF THE OSTOMY BARRIER. THE END USER WAS PRESCRIBED KENALOG SPRAY TO TREAT THE AREA.