MODERMA FLEX CONVEX CERAPLUS TAPE BORDERED CUT TO FIT POUCH
Received Mar 2, 2021 · Event occurred Feb 1, 2021
Report 9616668-2021-00004 · MDR key 11399349
Device
Generic name
Moderma Flex Convex Ceraplus Tape Bordered Cut To Fit Pouch
Manufacturer
Hollister IncorporatedCatalog number
54600
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
68 YR
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
THIS PRODUCT SKU, 54600, IS NOT SOLD IN THE US BUT IS EQUIVALENT TO 8918, PREMIER ONE-PIECE DRAINABLE OSTOMY POUCH WHICH IS SOLD IN THE US. END USER'S EXACT WEIGHT NOT KNOWN SO AN ESTIMATE WAS USED. LOT NUMBER AND SAMPLE NOT AVAILABLE SO A DHR REVIEW AND SAMPLE EVALUATION IS NOT POSSIBLE. TREND ANALYSIS WAS CONDUCTED FOR TAPE CAUSING SKIN IRRITATION FOR BOTH 54600 AND 8918 AND NO ADVERSE TRENDS OBSERVED. THE ROOT CAUSE OF THE END USER'S SKIN REACTION TO THE TAPE IS NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER STARTED EXPERIENCING A SKIN REACTION TO THE TAPE BORDER OF THE HOLLISTER OSTOMY BARRIER. THERE WERE NO ISSUES AT THE BEGINNING BUT DEVELOPED SENSITIVITIES AFTER A FEW WEEKS. THE SKIN WAS RED AND IRRITATED. SHE WAS PRESCRIBED A STEROID OINTMENT FOR HER SKIN. SHE IS NOW USING A DIFFERENT OSTOMY APPLIANCE WITHOUT ANY REPORTED ISSUES.