NEW IMAGE OSTOMY BARRIER

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 AN END USER WHO HAD PREVIOUSLY USED A SKIN PROTECTANT WIPE BENEATH A HOLLISTER CONVEX OSTOMY BARRIER WAS TRAILING A HOLLISTER SOFT CONVEX CERAPLUS BARRIER WITHOUT THE SKIN PROTECTANT, DURING WHICH BLISTERS FORMED UNDER THE TAPE BORDER. IT WAS FURTHER REPORTED THAT THE BLISTERS RUPTURED, PROMPTING A VISIT TO AN URGENT CARE FACILITY WHERE A MEDICAL PROFESSIONAL PRESCRIBED A TOPICAL ANTIBIOTIC OINTMENT FOR THE BROKEN SKIN AND PROVIDED SAMPLES OF A STEROID TOPICAL TREATMENT FOR ADJACENT ERYTHEMATOUS, NON-BROKEN SKIN. IT WAS SUBSEQUENTLY REPORTED THAT THE AREA IS HEALING, AND THE USER HAS RESUMED USE OF THE ORIGINAL HOLLISTER CONVEX OSTOMY BARRIER ALONG WITH THE SKIN PROTECTANT WIPES.