PREMIER

Additional Manufacturer Narrative

THE POUCH 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 WAS CONDUCTED, AND THE RECORDS WERE FOUND TO BE COMPLETE AND ACCURATE. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE OF LOCK 'N ROLL CLOSURE OPENING ON ITS OWN COULD NOT BE DETERMINED. NO CAUSATION COULD BE ESTABLISHED BETWEEN THE FECAL EFFLUENT LEAKAGE AND THE REPORTED UTI. HOLLISTER WILL CONTINUE TO MONITOR THIS REPORTED ISSUE.

Description of Event or Problem

IT WAS REPORTED THAT THE LOCK 'N ROLL CLOSER AT THE BOTTOM OF THE HOLLISTER OSTOMY POUCH OPENED IN USE AND THE ILEOSTOMY FECAL MATERIAL LEAKED OUT. IT WAS FURTHER REPORTED THAT THE LEAKAGE GOT ON THE END USER'S LOWER ABDOMEN AND UPPER LEG AREA. IT WAS REPORTED THAT THE END USER THEN DEVELOPED A UTI AND THE END USER CONCLUDED THAT IT MUST HAVE BEEN FROM THE FECAL MATTER THAT LEAKED, CONTAMINATING HIS PENIS AREA. IT WAS REPORTED THAT THE END USER WENT TO THE ER WHERE THE UTI DIAGNOSIS WAS MADE, THEY DID NOT INDICATE WHAT CAUSED OR CONTRIBUTED TO THE UTI, AND THEY PRESCRIBED A 10-DAY COURSE OF ANTIBIOTICS TO TREAT THE UTI. ADDITIONALLY, IT WAS REPORTED THAT NOW, 4 DAYS LATER, HE IS FEELING BETTER AND HOLLISTER IS PROVIDING HIM SAMPLES OF AN OSTOMY POUCH WITH A DIFFERENT TYPE OF CLOSURE TO TRY.