NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
Received May 4, 2021 · Event occurred Mar 20, 2021
Report 1119193-2021-00013 · MDR key 11768558
Device
Generic name
New Image Ceraplus Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
11203
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
46 YR
- Skin Infection
- Skin Infection
Narrative
Additional Manufacturer Narrative
WEIGHT NOT PROVIDED SO ESTIMATE USED. DHR REVIEW NOT POSSIBLE BECAUSE LOT NUMBER NOT PROVIDED. TREND ANALYSIS CONDUCTED FOR REPORTS OF SKIN IRRITATION/FUNGAL INFECTIONS AND NO TRENDS FOUND. NO REPORT OF DEVICE MALFUNCTION. THE ROOT CAUSE OF THE END USER'S FUNGAL INFECTION IS NOT KNOWN. IT IS NOT KNOWN IF THE HOLLISTER BARRIER CAUSED OR CONTRIBUTED TO THE END USER'S REPORTED FUNGAL INFECTION.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER HAS RECENTLY DEVELOPED SKIN IRRITATION UNDER THE OSTOMY BARRIER WITHIN AN HOUR OF PUTTING IT ON. THE SKIN IS WEEPING IN SOME AREAS. THERE IS NO EFFLUENT LEAKAGE OCCURRING. THE DOCTOR DIAGNOSED HIM WITH A YEAST INFECTION AND PRESCRIBED HIM AN ANTI-FUNGAL POWDER. THE SKIN HAS BEEN GETTING BETTER SINCE USING THE POWDER.