NEW IMAGE CONVEX CERAPLUS SKIN BARRIER WITH TAPE BORDER
Received May 12, 2020 · Event occurred Apr 24, 2020
Report 1119193-2020-00009 · MDR key 10048116
Device
Generic name
New Image Convex Ceraplus Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
11403
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
37 YR
- Skin Irritation
- Skin Irritation
Narrative
Additional Manufacturer Narrative
END USER'S WEIGHT NOT KNOWN SO ESTIMATION USED. EVENT DETAILS ARE NOT KNOWN BECAUSE END USER COULD NOT BE REACHED. IT IS UNCLEAR IF THIS WAS AN ADVERSE EVENT BUT SINCE NYSTATIN WAS REPORTED, HOLLISTER CONSIDERS THIS TO BE A REPORTABLE MEDICAL INTERVENTION. BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. DHR REVIEW COULD NOT BE CONDUCTED BECAUSE LOT NUMBER WAS NOT PROVIDED. 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 AN END USER EXPERIENCED RED SKIN UNDER THE HOLLISTER OSTOMY BARRIER AND WAS HOSPITALIZED FOR IT. SHE WAS ALSO PRESCRIBED NYSTATIN POWDER AND THIS HAS HELPED.