NEW IMAGE FLEXTEND TAPE BORDERED BARRIER 2-1/4" FLG 1-3/4" PRESIZED OPENING
Received Nov 19, 2019 · Event occurred Sep 3, 2019
Report 1119193-2019-00041 · MDR key 9341071
Device
Generic name
New Image Flextend Tape Bordered Barrier 2-1/4" Flg 1-3/4" Presized Opening
Manufacturer
Hollister IncroporatedCatalog number
14709
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
65 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 LOT NUMBER NOT KNOWN. SAMPLES NOT AVAILABLE SO REVIEW NOT POSSIBLE. END USER'S WEIGHT NOT AVAILABLE SO AN ESTIMATION WAS USED IN THIS REPORT. THE ROOT CAUSE OF THE REPORTED SKIN IRRITATION CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER EXPERIENCED A RASH WITH SMALL AREAS OF SORES, BLISTERS AND BLEEDING UNDER THE BARRIER PORTION OF THE OSTOMY APPLIANCE. THE END USER WAS PRESCRIBED TOPICAL STEROIDS, HYDROGEL AND A DRESSING FOR THE AREA. THE END USER'S WOCN STATED THERE WAS NOTHING WRONG WITH THE OSTOMY BARRIER AND THAT HER SKIN IS JUST SENSITIVE. THE AREAS ARE NOW HEALING IN RESPONSE TO THE TREATMENT.