NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
Received Mar 10, 2020 · Event occurred Feb 24, 2020
Report 1119193-2020-00005 · MDR key 9813456
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
- Adverse Event Without Identified Device or Use Problem
Patient
47 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 NOT NUMBER NOT KNOWN. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. THE ROOT CAUSE OF THE SKIN IRRITATION AND BLISTERS IS NOT KNOWN. END USER'S WEIGHT NOT KNOWN SO ESTIMATION USED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER DEVELOPED SKIN IRRITATION AND BLISTERS UNDER THE HOLLISTER BARRIER. HE BELIEVES IT WAS FROM NOT CHANGING HIS BARRIER WHEN STOOL WAS LEAKING UNDER IT. THE DOCTOR PRESCRIBED A FUNGUS POWDER. HE STATES HIS SKIN HAS NOW CLEARED UP.