NEW IMAGE
Received Mar 19, 2024 · Event occurred Mar 14, 2024
Report 1119193-2024-00008 · MDR key 18935347
Device
Generic name
2-piece Ostomy Skin Barrier, Flextend
Manufacturer
Hollister IncorporatedModel number
16104Catalog number
16104
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
66 YR · Male
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
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 COULD NOT TAKE PLACE SINCE NO LOT NUMBER WAS PROVIDED. THERE WAS NO REPORT OF PRODUCT MALFUNCTION. BASED ON THE INFORMATION PROVIDED, A ROOT CAUSE COULD NOT BE DETERMINED. HOLLISTER WILL CONTINUE TO MONITOR THIS REPORTED ISSUE.
Description of Event or Problem
IT WAS REPORTED THAT OVER A YEAR AGO AN END USER EXPERIENCED SKIN IRRITATION UNDER THE TAPE BORDER OF THE HOLLISTER 16104 NEW IMAGE OSTOMY BARRIER. THE END USER REPORT THAT AT THAT TIME HE WAS PRESCRIBED CLOBETASOL CREAM BY HIS HEALTH CARE PROFESSIONAL. HE FURTHER REPORTED THAT THE CREAM CLEARED UP THE IRRITATION AND NOW HE IS SAMPLING BARRIERS WITHOUT THE TAPE BORDER.