NEW IMAGE CONVEX 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. ALTHOUGH THE LOT NUMBER WAS NOT KNOWN FOR CERTAIN, A DHR REVIEW WAS CONDUCTED ON A PROBABLE LOT NUMBER; 8G242 AND FOUND TO BE COMPLETE AND ACCURATE. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER EXPERIENCED A RED RASH AND A 1.5 CM SKIN ULCER UNDER THE TAPE BORDER OF THE BARRIER. A WOCN TREATED THE AREA WITH STEROID INJECTION AND CAUTERIZATION OF THE ULCER. A PETROLEUM JELLY MESH DRESSING WAS THEN PLACED ON THE ULCER. THE REDNESS HAS SINCE IMPROVED SUBSTANTIALLY.