NEW IMAGE CVXFT TP 44MM 1-3/4" FLG 19MM 3/4" PRESIZED
Received Jun 4, 2019 · Event occurred Apr 1, 2019
Report 1119193-2019-00016 · MDR key 8667244
Device
Generic name
New Image Convex Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
13902
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
56 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 NOT POSSIBLE BECAUSE LOT NUMBER NOT KNOWN. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. THE ROOT CAUSE OF THE PAINFUL RASH CANNOT BE DETERMINED BUT PREVIOUSLY KNOWN ALLERGY TO TAPES AND ADHESIVES CANNOT BE RULED OUT.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER, WITH A KNOWN ALLERGY TO TAPES AND ADHESIVES, BROKE OUT INTO A PAINFUL RASH UNDER THE TAPE PORTION OF THE OSTOMY APPLIANCE. A DERMATOLOGIST PRESCRIBED FLUOCINONIDE GEL FOR THE AREA.