NEW IMAGE

Description of Event or Problem

IT WAS REPORTED THAT THE NEW IMAGE OSTOMY BARRIER DID NOT ADHERE WELL TO THE SKIN. IT WAS REPORTED THAT THE LACK OF ADHESION ALLOWED THE SKIN BARRIER TO BUNCH UP UNDER THE ABDOMINAL HERNIA BINDER AND ABRADED THE STOMA RESULTING IN SOME BLEEDING AND A LOCAL INFECTION WITH PUSS. IT WAS FURTHER REPORTED THAT THE END USER WAS TAKEN TO THE ER AND TREATED WITH ANTIBIOTICS TO PREVENT IT FROM GETTING WORSE.

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 WAS COMPLETED BASED ON THE PRODUCT AND LOT NUMBER AND NO ISSUES WERE IDENTIFIED. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE COULD NOT BE DETERMINED. HOLLISTER WILL CONTINUE TO MONITOR THIS REPORTED ISSUE.