NEW IMAGE FLEXTEND TAPE BORDERED CUT TO FIT BARRIER
Received May 26, 2020 · Event occurred May 13, 2020
Report 1119193-2020-00011 · MDR key 10088093
Device
Generic name
New Image Flextend Tape Bordered Cut To Fit Barrier
Manufacturer
Hollister IncorporatedCatalog number
14603
Lot number
0A252
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
52 YR
- Skin Irritation
- Skin Irritation
Narrative
Additional Manufacturer Narrative
END USER'S WEIGHT NOT KNOWN SO ESTIMATION USED. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. DHR REVIEW CONDUCTED AND RESULTS FOUND TO BE COMPLETE AND ACCURATE. BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. THE ROOT CAUSE OF THE CONTACT DERMATITIS CANNOT BE DETERMINED BUT SOME INDIVIDUALS MAY STILL BE SENSITIVE TO A SPECIFIC MATERIAL THAT HAS MET ALL SENSITIZATION TEST REQUIREMENTS AND THE SEVERITY OF THEIR REACTION CANNOT BE PREDICTED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER EXPERIENCED A RASH UNDER THE TAPE PORTION OF THE BARRIER. SHE SAW A DERMATOLOGIST WHO DIAGNOSED IT AS CONTACT DERMATITIS AND PRESCRIBED TRIAMCINOLONE CORTICOSTEROID SPRAY. SHE HAS NOT STARTED USING IT YET. THE TAPE BORDER LIFTS UP FAIRLY QUICKLY NOW THAT SHE HAS A HERNIA. HOLLISTER WILL BE FOLLOWING UP WITH HER TO SEE IF A DIFFERENT BARRIER PRODUCT MAY WORK BETTER FOR HER.