NEW IMAGE CERAPLUS CUT TO FIT BARRIER
Received Jun 30, 2020 · Event occurred May 26, 2020
Report 1119193-2020-00013 · MDR key 10212650
Device
Generic name
New Image Ceraplus Cut To Fit Barrier
Manufacturer
Hollister IncorporatedCatalog number
15103
Lot number
9K172
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
72 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 SKIN IRRITATION 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 HAD PERFECT AND CLEAR PERI-STOMAL SKIN. THREE DAYS LATER WHEN THE HOLLISTER OSTOMY BARRIER WAS CHANGED, THE SKIN WAS BROKEN, RED, ITCHY, AND THERE WAS A LARGE DIAMOND SHAPE AREA THAT HAD A TOP LAYER OF SKIN REMOVED. END USER SAW A DERMATOLOGIST WHO PRESCRIBED CLOBETASOL CREAM. THE CREAM WAS USED FOR 3 - 4 DAYS AND THE SKIN IRRITATION HAS SINCE CLEARED UP AND THE END USER HAS NOT USED ANY PRESCRIPTIVE TREATMENT SINCE.