PREMIER
Received Jun 10, 2024 · Event occurred Nov 20, 2020
Report 1119193-2024-00011 · MDR key 19502893
Device
Generic name
1-piece Urostomy Pouch, Flextend
Manufacturer
Hollister IncorporatedModel number
8442Catalog number
8442
Lot number
3E052
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
65 YR · Male
- Rash
- Skin Inflammation/ Irritation
- Rash
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
THE BARRIER WAS NOT SAVED; THEREFORE, A DEVICE EVALUATION COULD NOT TAKE PLACE. A COMPLAINT HISTORY TREND ANALYSIS WAS CONDUCTED FOR SIMILAR COMPLAINTS AND NO ADVERSE TRENDS OBSERVED. A DEVICE HISTORY RECORDS (DHR) REVIEW WAS COMPLETED BASED ON THE PRODUCT AND LOT NUMBER AND NO ISSUES WERE IDENTIFIED. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE FOR THE SKIN STRIPPING AND RASH COULD NOT BE DETERMINED. HOLLISTER WILL CONTINUE TO MONITOR THIS REPORTED ISSUE.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER NOTICED THAT WHEN HE REMOVED THE HOLLISTER OSTOMY BARRIER FROM HIS SKIN, IT PULLED THE SKIN AWAY. THE END USER ALSO REPORTED THAT HE WAS EXPERIENCING SOME LEAKAGE UNDER THE BARRIER WHICH CAUSED THE SKIN TO BECOME RAW AND RASHY. HE FURTHER REPORTED THAT THIS STARTED SEVERAL MONTHS AFTER HIS STOMA SURGERY IN 2020 AND HE SAW A WOCN AND A DERMATOLOGIST FOR IT AT THAT TIME. HE REPORTED THAT HE WAS PRESCRIBED BETAMETHASONE, AND HE HAS BEEN USING BETAMETHASONE ON HIS SKIN AS NEEDED EVER SINCE.