inforMED
InjuryEXB

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

Model number

10481

Lot 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.