PREMIER ONE-PIECE DRAINABLE OSTOMY POUCH

Additional Manufacturer Narrative

TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. LOT NUMBER NOT PROVIDED SO DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED IRRITATION UNDER THE OSTOMY TAPE BORDER CANNOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED THAT AN END USER EXPERIENCED SKIN BURNING AND ITCHING SENSATION ON HER SKIN UNDER THE 8958 HOLLISTER PREMIER OSTOMY APPLIANCE. SHE STATED SHE NONETHELESS LEFT THE APPLIANCE IN PLACE UNTIL THE RETURN OF HER HOME HEALTH CARE NURSE 3 DAYS LATER. WHEN THE BARRIER WAS REMOVED, SHE REPORTED THERE WERE BLISTERS AND IRRITATION UNDER SOME AREAS OF THE TAPE BORDER. SHE STATED THE HOME HEALTH CARE NURSE CLEANSED THE AREA AND APPLIED A TRANSPARENT FILM DRESSING. THEN SHE SAID THE NURSE APPLIED AN OSTOMY APPLIANCE. TWO DAYS LATER, THE END USER REPORTED THAT SHE REMOVED THE APPLIANCE AND THE FILM DRESSING BECAUSE HER APPLIANCE WAS LEAKING. SHE REPORTED THAT THE AREA LOOKED JUST AS IRRITATED AND WAS INSTRUCTED BY HER HOME HEALTH CARE NURSE TO GO TO THE ER. THE END USER REPORTED THAT SHE WENT TO THE ER AND WAS TOLD SHE HAD A FEVER, WHICH INDICATED AN INFECTION AND WAS PLACED ON IV ANTIBIOTICS. END USER REPORTS THAT THE AREA IS NOW CLEARING UP AND WOULD LIKE HOLLISTER TO SUPPLIER WITH A DIFFERENT BARRIER.