NEW IMAGE SOFT CONVEX CERAPLUS TAPE BORDERED PRESIZED BARRIER
Received Jan 3, 2023 · Event occurred Dec 7, 2022
Report 1119193-2023-00001 · MDR key 16085424
Device
Generic name
New Image Soft Convex Ceraplus Tape Bordered Presized Barrier
Manufacturer
Hollister IncroporatedModel number
11905Catalog number
11905
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
71 YR · Female
- Erythema
- Skin Inflammation/ Irritation
- Erythema
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED FOR TAPE BORDER CAUSING SKIN IRRITATION FOR THIS SKU AND NO ADVERSE TRENDS OBSERVED. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED BECAUSE LOT NUMBER WAS NOT PROVIDED. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED SKIN IRRITATION UNDER THE OSTOMY TAPE BORDER CANNOT BE DETERMINED.
Description of Event or Problem
THE END USER REPORTED THAT SHE IS EXPERIENCING RED, RAW, WEEPING SKIN UNDER THE TAPE BORDER OF HER HOLLISTER OSTOMY BARRIER. SHE REPORTS HAVING A HISTORY OF SENSITIVITY TO MEDICAL TAPE. SHE STATED HER OSTOMY NURSE LOOKED AT THE SKIN AND SUGGESTED SHE SEE HER DOCTOR. SHE SAID SHE SAW HER DOCTOR ABOUT 3 WEEKS AGO AND HE SAID IT WAS PROBABLY A YEAST INFECTION AND PRESCRIBED NYSTATIN POWDER. SHE SAID THE AREA IS STILL WEEPY. HOLLISTER IS SENDING SAMPLES FOR HER TO TRY THAT DO NOT HAVE A TAPE BORDER.