PREMIER

Additional Manufacturer Narrative

THE BARRIER WAS NOT SAVED; THEREFORE, A DEVICE EVALUATION COULD NOT TAKE PLACE. A COMPLAINT HISTORY TREND ANALYSIS WAS CONDUCTED FOR SIMILAR COMPLAINTS AND NO ADVERSE TRENDS OBSERVED. A DEVICE HISTORY RECORDS (DHR) REVIEW COULD NOT BE CONDUCTED BECAUSE A LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. HOLLISTER WILL CONTINUE TO MONITOR THIS REPORTED ISSUE.

Description of Event or Problem

IT WAS REPORTED THAT THE END USER HAD BEEN EXPERIENCING IRRITATION AROUND THE STOMA UNDER THE HOLLISTER PREMIER BARRIER FOR A WHILE DUE TO LEAKAGE OF OUTPUT AND WENT TO THE ER IN MAY. IT WAS REPORTED THAT THE ER SAID TO USE THE NO STING GEL AND CREAM (PROVIDED BY THE ER), THEN POWDER UNDER THE BARRIER. IT WAS REPORTED THAT THE END USER WAS PRESCRIBED CLOTRIMAZOLE BETAMETHASONE CREAM 15 GM AND LIDOCAINE HYDROCHLORIDE GEL 100 MG. IT WAS REPORTED THAT THE END USER HAS CONTINUED TO USE THE PRESCRIBED TOPICAL MEDICATION WHENEVER THE SKIN IS IRRITATED FROM OUTPUT RESTING ON THE SKIN. IT WAS FURTHER REPORTED THAT THE END USER CALLED HOLLISTER BECAUSE THEY WERE RUNNING OUT OF OSTOMY SUPPLIES FROM FREQUENT APPLIANCE CHANGES AND HOLLISTER IS SENDING OUT SAMPLES OF DIFFERENT PRODUCTS FOR THEM TO TRY IN ORDER TO SEE IF IT WORKS BETTER FOR THEM.