inforMED
EXB

PREMIER

Received Sep 9, 2021 · Event occurred Jun 30, 2021

Report MW5103817 · MDR key 12452630

Device

Generic name

Collector, Ostomy

Product problems

  • Patient-Device Incompatibility

Patient

64 YR

  • Hypersensitivity/Allergic reaction
  • Rash
  • Blister
  • Skin Inflammation/ Irritation
  • Hypersensitivity/Allergic reaction
  • Rash
  • Blister
  • Skin Inflammation/ Irritation

Narrative

Description of Event or Problem

PT FOUND TO HAVE MODERATE REACTION TO HOLLISTER UROSTOMY POUCH WITH RED OPEN WEEPING RASH AND FORMATION OF LARGE OPEN PERISTOMAL WOUND. SYMPTOMS: SKIN RASH, URTICARIA PRURITUS, BLISTER.