SENSURA POUCH OSTOMY L11IN OD3/8-2 1/8IN 655ML
Received Aug 28, 2025 · Event occurred Aug 6, 2025
Report MW5175289 · MDR key 22911485
Device
Generic name
Collector, Ostomy
Manufacturer
Coloplast Manufacturing Us, LlcModel number
10481Lot number
10053573
Product problems
- Loss of or Failure to Bond
- Fluid/Blood Leak
- Loss of or Failure to Bond
- Fluid/Blood Leak
Patient
11 MO · Male
- Tissue Breakdown
- Tissue Breakdown
Narrative
Description of Event or Problem
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. WE ARE NOW NEEDING TO KEEP THE BABY NPO (NOTHING BY MOUTH) AND APPLYING SKIN OINTMENT TO HELP THE SKIN HEAL BEFORE WE RE-ATTEMPT OSTOMY BAG PLACEMENT. PROLONGED HOSPITAL STAY. PT CODE: 2681. DEVICE CODE: 1250, 1068. REFERENCE REPORTS: MW5175290, MW5175291.