NEW IMAGE CONVEX SKIN BARRIER WITH TAPE BORDER 44MM, 1 3/4 INCH PRE SIZED OPENIN
Received Dec 11, 2018 · Event occurred Sep 6, 2018
Report 1119193-2018-00047 · MDR key 8151001
Device
Generic name
New Image Convex Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
14904
Lot number
8I202
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
64 YR
- Swelling
- Swelling
Narrative
Additional Manufacturer Narrative
BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. DHR REVIEW WAS 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 AN END USER EXPERIENCED BLISTERS UNDER THE TAPE BORDER OF THE BARRIER. HE WAS PRESCRIBED A STEROID WITH ANTIFUNGAL CREAM, NYSTATIN OINTMENT, AND FLUOCINONIDE OINTMENT. THE SKIN IS NO LONGER BLISTERED.