inforMED
InjuryEXB

NEW IMAGE

Received May 2, 2025 · Event occurred Apr 15, 2025

Report 1119193-2025-00016 · MDR key 21949286

Device

Generic name

2-piece Ostomy Skin Barrier With Tape, Flextend

Model number

14703

Catalog number

14703

Lot number

3E232

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

69 YR · Female

  • Erythema
  • Skin Inflammation/ Irritation
  • Erythema
  • Skin Inflammation/ Irritation

Narrative

Description of Event or Problem

IT WAS REPORTED THAT AN END USER WHO HAD BEEN USING THE HOLLISTER NEW IMAGE OSTOMY BARRIER FOR OVER THREE YEARS STARTED EXPERIENCING SKIN INFLAMMATION AND REDNESS UNDER THE BARRIER OVER THE LAST MONTH. IT WAS FURTHER REPORTED THAT THE END USER TRIED STEROID SPRAY (TRIAMCINOLONE SPRAY) WHICH SEEMED TO HELP SOMEWHAT.

Additional Manufacturer Narrative

THE BARRIER WAS NOT SAVED; THEREFORE, A DEVICE EVALUATION COULD NOT TAKE PLACE. A COMPLAINT HISTORY TREND ANALYSIS WAS CONDUCTED FOR SIMILAR COMPLAINTS AND NO ADVERSE TRENDS OBSERVED. A DEVICE HISTORY RECORDS (DHR) REVIEW WAS CONDUCTED AND THE RECORDS WERE COMPLETE AND ACCURATE. THERE WAS NO REPORT OF PRODUCT MALFUNCTION. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE COULD NOT BE DETERMINED. HOLLISTER WILL CONTINUE TO MONITOR THIS REPORTED ISSUE.