NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
Received Sep 17, 2019 · Event occurred Jul 15, 2019
Report 1119193-2019-00037 · MDR key 9076563
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
67 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 IS NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER HAD A COLOSTOMY PERFORMED FOR HIS NEUROGENIC BOWEL. HE WAS DISCHARGED HOME WITH NYSTATIN POWDER AND A COMPETITOR'S SKIN PREP TO USE UNDER HIS APPLIANCE. HE WAS NOT TOLD HE HAD A YEAST OR FUNGAL SKIN INFECTION. WITHIN A WEEK OF SURGERY, HE EXPERIENCED BLISTERS AND RED WEEPY SKIN UNDER THE OSTOMY APPLIANCE. HE CONTINUES TO USE THE NYSTATIN POWDER AND SKIN PREP AND HE SAYS HIS SKIN IS IMPROVING.