MODERMA FLEX CERAPLUS TAPE BORDERED CUT TO FIT POUCH
Received Mar 2, 2021 · Event occurred Dec 27, 2020
Report 9616668-2021-00005 · MDR key 11399321
Device
Generic name
Moderma Flex Ceraplus Tape Bordered Cut To Fit Pouch
Manufacturer
Hollister IncorporatedCatalog number
54300
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
55 YR
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
THIS PRODUCT SKU, 54300, IS NOT SOLD IN THE US BUT IS EQUIVALENT TO 8901, 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 & BARRIER CAUSING SKIN IRRITATION FOR BOTH 54300 AND 8901 AND NO ADVERSE TRENDS OBSERVED. THE ROOT CAUSE OF THE END USER'S SKIN REACTION TO THE APPLIANCE IS NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT A HOSPITAL INPATIENT STARTED EXPERIENCING A SKIN REACTION TO THE HOLLISTER OSTOMY APPLIANCE AFTER A FEW DAYS OF USE. THE SKIN UNDER THE BARRIER AND TAPE PORTION WAS RED AND IRRITATED. SHE WAS PRESCRIBED A STEROID INHALER TO TREAT THE SKIN IRRITATION. THE SKIN HAS FULLY HEALED WITH THE USE OF THE INHALER AND A CHANGE OF OSTOMY APPLIANCE.