PREMIER

Additional Manufacturer Narrative

THE LOT NUMBER IS NOT KNOWN SO ONLY THE DI INFORMATION FROM THE UDI IS KNOWN. 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 SINCE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE 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 LEAKAGE AND EXPERIENCED SKIN BREAK DOWN WITH USING THE HOLLISTER PREMIER ONE-PIECE DRAINABLE OSTOMY POUCH - SOFT CONVEX FLEXTEND BARRIER. IT WAS REPORTED THAT THE END USER HAS A CREASE/FOLD IN HIS SKIN UNDERNEATH THE STOMA WHICH DOESN'T ALLOW FOR A GOOD SEAL AND ALLOWS THE ACCUMULATION OF EFFLUENT IN THIS CREASE. IT WAS REPORTED THAT THE END USER HAD BEEN SUFFERING WITH CROHN'S SINCE 1968.  IT WAS FURTHER REPORTED THAT THE END USER SAW HIS WOUND CARE DOCTOR WHO DETERMINED BY CULTURE THAT HE HAD EIGHT DIFFERENT BACTERIA'S GROWING. IT WAS REPORTED THAT HE WAS PRESCRIBED TWO ANTIBIOTICS (ORAL MEDICATION AND LEVOQUIN AND FLAGIL WHICH IS COMPOUNDED INTO A SPRAY). IT WAS FURTHER REPORTED THAT HE WAS PROVIDED WITH DIFFERENT SAMPLES FROM HOLLISTER THAT HE IS TRYING NOW.