NEW IMAGE CERAPLUS TAPE BORDERED CUT TO FIT BARRIER
Received Sep 20, 2022 · Event occurred Sep 12, 2022
Report 1119193-2022-00033 · MDR key 15454522
Device
Generic name
New Image Ceraplus Tape Bordered Cut To Fit Barrier
Manufacturer
Hollister IncroporatedCatalog number
11204
Lot number
2D092
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
77 YR · Male
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED FOR BARRIER AND TAPE CAUSING SKIN IRRITATION FOR THIS SKU AND NO ADVERSE TRENDS OBSERVED. DEVICE HISTORY RECORD (DHR) REVIEW CONDUCTED 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 IRRITATION UNDER THE OSTOMY BARRIER AND TAPE CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN OSTOMATE USING HOLLISTER NEW IMAGE BARRIER DEVELOPED A SKIN REACTION UNDER THE BARRIER. THE END USER REPORTED THAT HE NOTICED A DRY RED REACTION ON HIS SKIN AFTER REMOVING THE SKIN BARRIER AT HIS USUAL 3-DAY WEAR TIME. END USER REPORTED THAT HIS DOCTOR TREATED HIM WITH A COURSE OF ANTIBIOTICS AND TOPICAL STEROID CREAM. HE REPORTED THAT THE TREATMENT HAS HELPED REDUCE THE REDNESS. HOLLISTER IS SAMPLING SOME ALTERNATIVE BARRIERS FOR THE END USER TO TRY.