NEW IMAGE FLEXTEND SKIN BARRIER WITH TAPE BORDER 1" PS
Received May 21, 2019 · Event occurred Feb 7, 2019
Report 1119193-2019-00014 · MDR key 8628906
Device
Generic name
New Image Flextend Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
14704
Lot number
8K182
Product problems
- Patient-Device Incompatibility
Patient
89 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 CONDUCTED AND FOUND TO BE COMPLETE AND ACCURATE. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED.
Description of Event or Problem
IT WAS REPORTED THAT IN FEBRUARY THE END USER EXPERIENCED BURNING AND REDNESS ON THE SKIN UNDER THE TAPE BORDER OF THE 14704 SKIN BARRIER. HE WENT TO THE DOCTOR WHO PRESCRIBED NYSTATIN POWDER TO USE UNDER THE TAPE BORDER. IT DID NOT CLEAR UP COMPLETELY SO THE DOCTOR PRESCRIBED STEROID PILLS AND CREAM. THE END USER ALSO CUT THE TAPE BORDER OFF THE BARRIER. THIS CLEARED THINGS UP. THE BURNING AND REDNESS RETURNED WHEN HE STOPPED CUTTING OFF THE TAPE BORDER.