HOLLISTER PREMIER FLEXTEND CUT TO FIT UROSTOMY APPLIANCE
Received Dec 21, 2021 · Event occurred Oct 8, 2021
Report 1119193-2021-00036 · MDR key 13053193
Device
Generic name
Hollister Premier Flextend Cut To Fit Urostomy Applianceappliance
Manufacturer
Hollister IncroporatedCatalog number
84590
Lot number
1H042
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
64 YR · Male
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. DHR REVIEW COMPLETED AND NO ISSUES IDENTIFIED. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED BLISTERS UNDER THE TAPE BORDER CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER DEVELOPED BLISTERS UNDER THE TAPE BORDER OF THE HOLLISTER PREMIER OSTOMY APPLIANCE IN THE BEGINNING OF OCTOBER. HE HAS BEEN PRESCRIBED NYSTOP ANTIFUNGAL POWDER. HOLLISTER WILL SEND OUT A DIFFERENT BARRIER PRODUCT THAT DOES NOT HAVE A TAPE BORDER.