CONFORM 2 FLEXTEND CUT TO FIT OSTOMY BARRIER
Received Apr 18, 2022 · Event occurred Mar 25, 2022
Report 3016675012-2022-00001 · MDR key 14135100
Device
Generic name
Conform 2 Flextend Cut To Fit Ostomy Barrier
Manufacturer
Hollister IncroporatedCatalog number
35500
Lot number
1H169
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
ALTHOUGH HOLLISTER DOES NOT SELL SKU 35500 IN THE US, A SIMILAR OSTOMY BARRIER PRODUCT, SKU 14203, IS SOLD IN THE US. TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED OVER THE LAST 3 YEARS. DEVICE HISTORY RECORDS (DHR) REVIEW CONDUCTED AND WAS FOUND TO BE COMPLETE AND ACCURATE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF THE SKIN REACTION TO THE ADHESIVE CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN OSTOMATE WAS EXPERIENCING A SKIN REACTION TO THE HOLLISTER CONFORM 2 OSTOMY BARRIER 10 DAYS AFTER SURGERY. IT WAS REPORTED THAT THEY CHANGED THE APPLIANCE TO A CONVEX BARRIER TO SEE IF IT IMPROVED THINGS, BUT IT DID NOT. IT WAS FURTHER REPORTED THAT THE PERSON SAW A DERMATOLOGIST FOR THE SKIN REACTION TO THE ADHESIVE ON THE BARRIER AND WAS PRESCRIBED A CORTICOÏDE MEDICATION. IT IS REPORTED THAT THE SKIN REACTION HAS NOT RESOLVED YET.