NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
Received Mar 3, 2020 · Event occurred Jan 29, 2019
Report 1119193-2020-00004 · MDR key 9780830
Device
Generic name
New Image Ceraplus Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
11203
Lot number
0A132
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
61 YR
- Skin Irritation
- Skin Irritation
Narrative
Additional Manufacturer Narrative
BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. DHR REVIEW CONDUCTED AND NO ISSUES IDENTIFIED. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. ROOT CAUSE OF THIS REPORTED ISSUE CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT THE END USER HAD COLOSTOMY SURGERY ON (B)(6) 2018 AND STARTED HAVING SKIN IRRITATION UNDER THE NEW IMAGE OSTOMY BARRIER IN (B)(6) 2019. SHE SAW HER DERMATOLOGIST NUMEROUS TIMES AND WAS PRESCRIBED NYSTATIN FUNGAL POWDER ON (B)(6) 2019 AND CLOBETASOL STEROID CREAM ON (B)(6) 2019 TO ADDRESS THE IRRITATION. NEITHER COMPLETELY WORKED. SHE IS NOW EXPERIENCING WEEPY SKIN BELOW THE STOMA. SHE IS USING A LIQUID SKIN BARRIER WITH SOME RELIEF. THE DOCTOR SAID THAT HER SKIN ISSUES MAY BE RELATED TO HER ULCERATIVE COLITIS. SHE WILL CONTINUE TO WORK WITH HER VISITING NURSE TO SEE IF OTHER BARRIER SAMPLES HELP HER SKIN.