NEW IMAGE CONVEX FLEXTEND SKIN BARRIER WITH TAPE BORDER

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 IS NOT POSSIBLE. SAMPLE NOT RETURNED SO A SAMPLE EVALUATION IS NOT POSSIBLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. DESPITE NUMEROUS ATTEMPTS, NO FURTHER EVENT INFORMATION COULD BE OBTAINED. END USER'S AGE AND WEIGHT ESTIMATED BECAUSE ACTUAL INFORMATION IS NOT KNOWN.

Description of Event or Problem

AN END USER REPORTED THAT THE ADHESIVE ON THE OSTOMY BARRIER PRODUCTS SOMETIMES CAUSES IRRITATION. A DOCTOR PRESCRIBED A POWDER AND ANTIBIOTICS. NO FURTHER INFORMATION IS KNOWN.