NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
Received Mar 24, 2020 · Event occurred Aug 1, 2019
Report 1119193-2020-00006 · MDR key 9872369
Device
Generic name
New Image Ceraplus Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
11203
Lot number
9D072
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
60 YR
- Skin Irritation
- Skin Irritation
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 NO ISSUES IDENTIFIED. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. ROOT CAUSE OF THIS REPORTED ISSUE CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT THE END USER HAD COLOSTOMY SURGERY IN (B)(6) 2017. IN (B)(6) 2019 HE STARTED HAVING RED, ITCHY RASH WHEREVER THE BARRIER TOUCHED HIS SKIN UNDER THE NEW IMAGE OSTOMY BARRIER. HE TRIED MANAGING THE IRRITATION ON HIS OWN BUT THE AREA DID NOT IMPROVE. HE WENT TO HIS DOCTOR IN (B)(6) 2019 AND WAS PROVIDE TRIAMCINOLONE ACETONIDE OINTMENT 0.1%. THE AREA CLEARED UP WITH THE USE OF THE OINTMENT BUT THEN RECURRED. HOLLISTER CUSTOMER SERVICE IS SENDING OUT DIFFERENT SAMPLES FOR HIM TO TRY.