NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
Received Jul 16, 2019 · Event occurred Jun 26, 2019
Report 1119193-2019-00030 · MDR key 8794279
Device
Generic name
New Image Ceraplus Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
11204
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR
- Fungal Infection
- Fungal Infection
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 NOT NUMBER NOT KNOWN. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. END USER'S WEIGHT ESTIMATED BECAUSE ACTUAL WEIGHT IS NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER DEVELOPED A FUNGAL INFECTION AROUND THE EDGES OF THE OSTOMY APPLIANCE. HE APPLIED NYSTATIN TO THE SKIN. NO FURTHER INFORMATION IS KNOWN.