NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
Received Oct 29, 2019 · Event occurred Mar 26, 2019
Report 1119193-2019-00039 · MDR key 9250812
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
51 YR
- Erythema
- Erythema
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 EVENT CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER HAS HAD RED ITCHY BUMPS UNDER HER HOLLISTER OSTOMY BARRIER SINCE (B)(6) OF 2019. SHE SAW HER DOCTORS WHO PRESCRIBED HYDROCORTISONE 2.5% FOR THE ITCHING AND NYSTOP ANTIFUNGAL TOPICAL POWDER. HER SKIN CONTINUES TO BE RED AND ITCHY AT TIMES. SHE CONTINUES TO USE THE MEDICINES AS NEEDED. SHE IS SCHEDULED FOR A STOMA REVERSAL AT THE BEGINNING OF NOVEMBER.