NEW IMAGE FLAT FORMAFLEX SKIN BARRIER WITH TAPE BORDER

Additional Manufacturer Narrative

SAMPLE NOT RETURNED SO A SAMPLE EVALUATION IS NOT POSSIBLE. LOT NUMBER NOT KNOWN SO DHR REVIEW IS NOT POSSIBLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. THE ROOT CAUSE OF THE REPORTED ROUND, RAISED BUMPS ON THE END USER'S PERISTOMAL SKIN CANNOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT THE END USER EXPERIENCED RED, RAISED, PAINFUL BUMPS ON HER PERISTOMAL SKIN UNDER THE NEW IMAGE BARRIER. SHE DENIES ANY EFFLUENT LEAKAGE ONTO HER SKIN. THE DOCTOR THOUGHT IT MIGHT BE A YEAST INFECTION AND PRESCRIBED DIFLUCAN ORAL MEDICATION. THE BUMPS REMAIN SO SHE WILL TRY A DIFFERENT BARRIER FORMULATION.