NEW IMAGE SOFT CONVEX CERAPLUS TAPE BORDERED PRESIZED BARRIER
Received Nov 2, 2022 · Event occurred Oct 20, 2022
Report 1119193-2022-00036 · MDR key 15715002
Device
Generic name
New Image Soft Convex Ceraplus Tape Bordered Presized Barrier
Manufacturer
Hollister IncroporatedModel number
11904Catalog number
11904
Lot number
2E202
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
60 YR · Female
- Erythema
- Skin Inflammation/ Irritation
- Erythema
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED FOR BARRIER USE CAUSING SKIN IRRITATION FOR THIS SKU AND NO ADVERSE TRENDS OBSERVED. DEVICE HISTORY RECORD (DHR) REVIEW CONDUCCTED BASED UPON THE LOT NUMBER PROVIDED AND THE RECORDS WERE FOUND TO BE COMPLETE AND ACCURATE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED SKIN REDNESS AND IRRITATION UNDER THE OSTOMY BARRIER CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN OSTOMATE USING HOLLISTER'S NEW IMAGE BARRIER DEVELOPED SKIN THAT WAS RED AND RAW UNDER THE BARRIER. SHE REPORTED THAT SHE CALLED HER DOCTOR AND ASKED FOR SOMETHING TO BE PRESCRIBED. SHE STATED THAT SHE DID NOT SEE HER DOCTOR BUT WAS PRESCRIBED NYSTATIN CREAM OVER THE PHONE BASED ON WHAT SHE DESCRIBED TO HER DOCTOR. THE END USER REPORTED THAT SINCE SHE STARTED USING THE CREAM, THE RED AND RAW AREA UNDER THE BARRIER IS ALREADY IMPROVING.