NEW IMAGE CERAPLUS 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. DHR REVIEW NOT POSSIBLE BECAUSE NOT NUMBER NOT KNOWN. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. END USER'S AGE AND WEIGHT ESTIMATED BECAUSE ACTUAL WEIGHT IS NOT KNOWN. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT END USER DEVELOPED REACTION WITH REDNESS AND BLISTERS UNDER THE TAPE BORDER OF THE OSTOMY BARRIER. THE BLISTERS OPENED AND END USER DEVELOPED CELLULITIS. END USER WAS PRESCRIBED ANTIBIOTICS TO TREAT THE AREA.