NEW IMAGE CONVEX FLEXTEND TAPE BORDERED PRESIZED BARRIER
Received Jul 28, 2020 · Event occurred Jan 27, 2020
Report 1119193-2020-00020 · MDR key 10333348
Device
Generic name
New Image Convex Flextend Tape Bordered Presized Barrier
Manufacturer
Hollister IncorporatedCatalog number
14902
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
59 YR
- Skin Irritation
- Skin Irritation
Narrative
Additional Manufacturer Narrative
TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. DHR REVIEW COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER IS NOT KNOWN. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. THE ROOT CAUSE OF THE SKIN IRRITATION CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER HAS BEEN EXPERIENCING RED, BUMPY, IRRITATED SKIN UNDER THE TAPE AND BARRIER PORTION OF THE HOLLISTER OSTOMY APPLIANCE FOR THE PAST 2 YEARS. SIX MONTHS AGO SHE STARTED USING CLOBETASOL PROPIONATE TOPICAL SOLUTION ON THE IRRITATED AREAS. IT CLEARS IT UP BUT WHEN SHE STOPS USING THE SOLUTION, THE IRRITATED SKIN RETURNS. SHE HAS BEEN REFERRED TO THE HOLLISTER CUSTOMER SERVICE GROUP SO SHE CAN TRIAL OTHER PRODUCTS.