PREMIER CONVEX TAPE BORDERED UROSTOMY POUCH WITH 1-1/2" PRE-SIZED OPENING

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. THE ROOT CAUSE OF THE GENERALIZED RASH AND ITCHING CANNOT BE DETERMINED. ALTHOUGH IT HAS NOT BEEN DEFINITIVELY DETERMINED THAT THE HOLLISTER UROSTOMY POUCH CAUSED THE END USER'S GENERALIZED RASH AND ITCHING, THIS REPORT IS BEING FILED AS A REPORTABLE EVENT TO THE FDA SINCE THE HOLLISTER DEVICE WAS BEING USED WHEN THE SYMPTOMS DEVELOPED.

Description of Event or Problem

IT WAS REPORTED THAT ONE TO TWO MONTHS AFTER THE END USER STARTED USING THE HOLLISTER UROSTOMY APPLIANCE, HE DEVELOPED A GENERALIZED SKIN RASH AND ITCHING. ALTHOUGH THE SKIN RASH WAS GENERALIZED, IT DID NOT OCCUR UNDER THE OSTOMY APPLIANCE. THE DOCTOR PREFORMED A SKIN BIOPSY AND PRESCRIBED TRIAMCINOLONE CREAM. THE END USER HAS BEEN USING THE CREAM ON AREAS NOT UNDER THE APPLIANCE AND IT HAS BEEN HELPING.