NEW IMAGE

Additional Manufacturer Narrative

THE LOT NUMBER WAS NOT PROVIDED, SO A DHR WAS NOT ABLE TO BE PERFORMED. THE UDI NUMBER IS UNKNOWN, DUE TO NO KNOWN LOT, SO THE DI WAS ENTERED. THE SAMPLE IS UNAVAILABLE FOR EVALUATION. ROOT CAUSE WAS UNABLE TO BE ESTABLISHED. THIS APPEARS TO BE AN ISOLATED EVENT. IT IS NOT KNOWN HOW OR IF THE COLOSTOMY POUCH LEAKING CAUSED OR CONTRIBUTED TO THE REPORTED URINARY TRACT INFECTIONS. HOLLISTER INCORPORATED WILL CONTINUE TO MONITOR THIS TYPE OF ISSUE IN OUR POST-MARKET SURVEILLANCE SYSTEM.

Description of Event or Problem

IT WAS REPORTED THAT THE LAST TWO BOXES OF HOLLISTER COLOSTOMY POUCHES THAT THE END USER RECEIVED HAD POUCHES THAT WERE OPEN AS IF THEY WERE "CUT WITH A RAZOR BLADE". IT WAS FURTHER REPORTED THAT THE OUTPUT LEAKED ALL OVER THE END USER AND THAT HE EXPERIENCED MULTIPLE BLADDER INFECTIONS FROM IT. ADDITIONALLY, IT WAS REPORTED THAT THE END USER WAS SICK AND HOSPITALIZED FOR THE BLADDER INFECTIONS. DESPITE MULTIPLE ATTEMPTS, HOLLISTER WAS UNABLE TO OBTAIN FURTHER EVENT INFORMATION.