NEW IMAGE

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. REGARDING UDI INFORMATION, ONLY THE DI INFORMATION IS AVAILABLE. SINCE THE LOT NUMBER WAS NOT PROVIDED, THE PI INFORMATION IS NOT AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT SKIN IRRITATION DEVELOPED UNDER THE BARRIER OF THE HOLLISTER NEW IMAGE SOFT CONVEX OSTOMY BARRIER. IT WAS REPORTED THAT IT HAD BEEN GOING ON FOR SEVERAL MONTHS, NOT SPECIFIC TO ANY PARTICULAR LOT OF PRODUCT, AND HADN'T BEEN CLEARING UP. IT WAS FURTHER REPORTED THAT THEY DIDN'T REALIZE IT WAS FROM EFFLUENT SEEPING UNDER THE BARRIER IRRITATING THE SKIN. IT WAS REPORTED THAT THE END USER WENT TO A DERMATOLOGIST A FEW TIMES AND HE WAS PRESCRIBED A LIQUID TO USE UNDER THE BARRIER ON THE SKIN. IT WAS REPORTED THAT THE DERMATOLOGIST SAID THE SEEPING WAS PROBABLY FROM THE BARRIER NOT ADHERING WELL DUE TO THE PRESENCE OF A HERNIA AND SUGGESTED THEY TRY AN OSTOMY BELT. IT WAS REPORTED THAT THE LIQUID ON THE SKIN IS HELPING, AND THE SKIN IS NOW HEALING.