NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER 1-1/4" CTF

Additional Manufacturer Narrative

BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. DHR REVIEW NOT POSSIBLE BECAUSE LOT NUMBER NOT KNOWN. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. WEIGHT OF END USER NOT KNOWN SO ESTIMATION WAS USED.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER RECEIVED HIS STOMA IN 2016 AND ALMOST IMMEDIATELY, NOTICED RED IRRITATION UNDER THE TAPE PORTION OF HIS BARRIER. HIS DOCTOR PRESCRIBED NYSTATIN POWDER, HAD HIM USE A SPRAY, AND THEN APPLY HIS APPLIANCE. THE RED IRRITATION NEVER WENT AWAY DESPITE USING THE POWDER AND SPRAY. HE SAW A NURSE YESTERDAY WHO SAID TO STOP USING THE POWDER AND SPRAY, CUT OFF THE TAPE BORDER AND USE A DIFFERENT TAPE. HE DID THIS AND THINGS ARE NOW IMPROVING.