CERAPLUS TAPE BORDERED BARRIER DRAINABLE

Additional Manufacturer Narrative

THIS MDR IS FOR A SIMILAR PRODUCT SOLD IN THE US. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. LOT NUMBER NOT PROVIDED, SO A DHR CANNOT BE PERFORMED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. HOLLISTER WILL CONTINUE TO MONITOR FOR THIS TYPE OF ISSUE IN OUR POST-MARKET SURVEILLANCE SYSTEM.

Description of Event or Problem

IT WAS REPORTED THAT THE END USER WHO WAS USING THE HOLLISTER MODERMAFLEX SOFT CONVEX CERAPLUS ONE-PIECE OSTOMY POUCH DEVELOPED SKIN IRRITATION AND SAW A DERMATOLOGIST. IT WAS REPORTED THAT STEROIDS WERE PRESCRIBED AND THE SKIN CONDITION WAS REPORTED TO BE "IMPROVED".