NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
Received Nov 5, 2019 · Event occurred Oct 23, 2019
Report 1119193-2019-00040 · MDR key 9279989
Device
Generic name
New Image Ceraplus Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
11202
Lot number
UNKNOWN
Product problems
- Patient-Device Incompatibility
Patient
69 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.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER EXPERIENCED PAIN AND BLISTERING UNDER THE TAPE PORTION OF THE OSTOMY BARRIER WITHIN WEEKS OF USE. HE SAW A DERMATOLOGIST WHO PRESCRIBED AN ANTIFUNGAL OINTMENT AND AN ANTIBIOTIC OINTMENT TO USE ON THE AREA FOR 7 DAYS. THE AREA HAS NOW CLEARED UP. END USER WILL TRY HOLLISTER'S TAPELESS BARRIER.