SENSURA MIO OSTOMY BAG 1-PIECE OPEN

Description of Event or Problem

THIS COMPLAINT CONCERNS A TEN-MONTH-OLD MALE WHO HAD UNDERGONE ILEOCECECTOMY WITH CREATION OF END ILEOSTOMY DEVELOPED ISSUES WITH LEAKAGE AROUND THE OSTOMY BAG (OSTOMY APPLIANCE WAS NOT SEALING WELL TO THE SKIN AND THIS LED TO THE DEVELOPMENT OF SKIN BREAKDOWN WHICH LED TO THE BAG BEING UNABLE TO STICK). MULTIPLE SURGEONS WENT BEDSIDE IN AN EFFORT TO GET THE BAG TO STICK TO THE SKIN BETTER, HOWEVER THE LONGEST THE BAG LASTED WAS 6-7 HOURS. THEY ARE NOW NEEDING TO KEEP THE BABY NPO (NOTHING BY MOUTH) AND APPLYING SKIN OINTMENT TO HELP THE SKIN HEAL BEFORE RE-ATTEMPTING OSTOMY BAG PLACEMENT. PROLONGED HOSPITAL STAY. THERE ARE THREE DIFFERENT LOT NUMBERS CORRELATED TO THIS COMPLAINT THE OTHER TWO BEING (B)(4) AND (B)(4). WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.