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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 HAS BEEN RECEIVING CHEMO FOR THE LAST 4 YEARS. IT WAS REPORTED THAT DURING THIS WHOLE TIME, URINE HAS BEEN LEAKING UNDER THE UROSTOMY BARRIER AND BURNING HIS SKIN FROM THE CHEMOTHERAPY IN THE URINE. IT WAS REPORTED THAT THE SKIN LOOKS LIKE A 3RD DEGREE BURN, IRRITATED, AND WAS NOT GETTING ANY BETTER. IT WAS FURTHER REPORTED THAT THE DOCTOR PRESCRIBED ORAL PREDNISONE 3 DAYS AGO FOR A 5-DAY TAPERING SCHEDULE. IT WAS REPORTED THAT THE SKIN IS ALREADY FEELING BETTER. HOLLISTER IS SENDING OUT SAMPLES OF OTHER PRODUCTS TO TRY.