HOLLISTER PREMIER CONVEX TAPE BORDERED PRE-SIZED UROSTOMY APPLIANCE
Received Dec 14, 2021 · Event occurred Sep 8, 2021
Report 1119193-2021-00039 · MDR key 13002708
Device
Generic name
Hollister Premier Convex Tape Bordered Pre-sized Urostomy Appliance
Manufacturer
Hollister IncroporatedCatalog number
8481
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
80 YR · Female
- Itching Sensation
- Urticaria
- Itching Sensation
- Urticaria
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. SINCE LOT NUMBER NOT PROVIDED A DHR REVIEW NOT POSSIBLE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED RASH UNDER THE BARRIER CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER WHO WAS USING THE HOLLISTER PREMIER OSTOMY APPLIANCE DEVELOPED SKIN IRRITATION, REDNESS AND ITCHING UNDER HER BARRIER. THE DOCTOR PRESCRIBED NYSTATIN PILLS AND CREAM. THAT HELPED A LITTLE, BUT THEN THE BARRIER WOULD NOT ADHERE. SHE WILL BE ASKING HER DOCTOR FOR NYSTATIN POWDER. IN ADDITION, HOLLISTER WILL SEND HER A DIFFERENT FORMULATION OF HOLLISTER'S OSTOMY BARRIERS WITHOUT A TAPE BORDER TO SEE IF THAT IMPROVES HER SKIN.