NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
Received Jun 11, 2019 · Event occurred May 24, 2019
Report 1119193-2019-00024 · MDR key 8687594
Device
Generic name
New Image Ceraplus Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
11203
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
60 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 NOT POSSIBLE BECAUSE LOT NUMBER NOT KNOWN. 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 EXPERIENCED SKIN IRRITATION UNDER THE OSTOMY BARRIER TAPE SINCE FEBRUARY. HER SKIN WAS RED AND WEEPY. THE REDNESS EXTENDED OUT PAST THE TAPE BORDER A LITTLE BIT. SHE WAS USING PINK TAPE OVER THE BARRIER TAPE BORDER TO HOLD THE BARRIER AND TAPE IN PLACE. SHE SAW THE DOCTOR AROUND MAY 24 AND WAS PRESCRIBED NYSTATIN POWDER TO TREAT A POSSIBLE YEAST INFECTION. HOLLISTER IS SENDING HER A TAPELESS BARRIER PRODUCT TO TRY.