NEW IMAGE FLEXTEND PRE SIZED BARRIER
Received May 25, 2021 · Event occurred Jan 31, 2021
Report 1119193-2021-00015 · MDR key 11877637
Device
Generic name
New Image Flextend Pre Sized Barrier
Manufacturer
Hollister IncorporatedCatalog number
14703
Lot number
1B052
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
48 YR
- Skin Infection
- Contact Dermatitis
- Skin Infection
- Contact Dermatitis
Narrative
Additional Manufacturer Narrative
THE END USER'S WEIGHT IS NOT KNOWN SO AN ESTIMATE WAS USED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE COMPLETE AND ACCURATE. THE DEVICE NOT SAVED FOR RETURN SO DEVICE EVALUATION NOT POSSIBLE. THE TREND ANALYSIS CONDUCTED SHOWED NO ADVERSE TRENDS FOR SKIN IRRITATION. THE ROOT CAUSE OF THE REPORTED FUNGAL INFECTION AND CONTACT DERMATITIS IS NOT KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER WHO HAD BEEN USING HOLLISTER OSTOMY BARRIERS SINCE 2013, STARTED DEVELOPING SKIN IRRITATION UNDER THE BARRIER AND TAPE PORTION OF THE APPLIANCE IN (B)(6) SHE HAS BEEN SEEN BY SEVERAL HEALTH CARE PROFESSIONALS AND PRESCRIBED NYSTATIN POWDER, STEROID PILLS AND STEROID CREAM AND SEEING SOME RELIEF BUT THE IRRITATION IS STARTING BACK UP AGAIN UNDER THE TAPE BORDER. SHE HAD BEEN DIAGNOSED WITH A FUNGAL INFECTION AND THEN WITH DERMATITIS. HOLLISTER WILL SEND OUT A DIFFERENT BARRIER PRODUCT FOR HER TO SAMPLE.