NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
Received Feb 5, 2019 · Event occurred Jan 9, 2019
Report 1119193-2019-00006 · MDR key 8305806
Device
Generic name
New Image Ceraplus Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
11203
Lot number
UNKNOWN
Product problems
- Patient-Device Incompatibility
Patient
26 YR
- Wheal(s)
- Wheal(s)
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.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER EXPERIENCED BLISTERS AND A RASH WHICH STARTED UNDER THE TAPE PORTION OF THE OSTOMY BARRIER BUT EXTENDED TO HER STOMACH AND DOWN HER LEGS. END USER WAS PRESCRIBED HYDROCORTISONE CREAM 2.5% BY HER DOCTOR. SHE SWITCHED TO A TAPELESS BARRIER AND THE AREA IS NOW IMPROVING.