NEW IMAGE FLEXTEND TAPE BORDERED BARRIER 2-1/4" FLG 1-3/4" PRESIZED OPENING
Received Jun 11, 2019 · Event occurred Jun 5, 2019
Report 1119193-2019-00025 · MDR key 8687596
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
94 YR
- Skin Inflammation
- Skin Inflammation
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. SAMPLE REVIEW NOT POSSIBLE. THE ROOT CAUSE OF THE REPORTED SKIN IRRITATION CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER DEVELOPED SKIN INFLAMMATION UNDER THE OSTOMY BARRIER & TAPE, EXTENDING BEYOND THE BARRIER ABOUT 3 INCHES. ONE AREA NEXT TO THE STOMA HAD SKIN STRIPPING AND WAS WEEPING. SHE WENT TO THE DOCTOR ON JUNE 5TH WHO PRESCRIBED CIPRO AND FLAGYL. THE SKIN HAS ALREADY IMPROVED. THE INFLAMMATIONS IS ALMOST GONE AND THE WEEPY AREA HAS DRIED.