PREMIER FLAT OSTOMY LNR POUCH WITH CUT TO FIT BARRIER
Received Sep 25, 2023 · Event occurred Sep 19, 2023
Report 1119193-2023-00007 · MDR key 17809611
Device
Generic name
Premier Flat Ostomy Lnr Pouch With Cut To Fit Barrier
Manufacturer
Hollister IncroporatedCatalog number
8331
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
79 YR · Male
- Skin Infection
- Skin Infection
Narrative
Additional Manufacturer Narrative
LOT NUMBER NOT PROVIDED SO DHR REVIEW NOT POSSIBLE. SAMPLE NOT RETURNED SO SAMPLE REVIEW NOT POSSIBLE. ROOT CAUSE OF REPORTED FUNGAL INFECTION UNDER THE OSTOMY APPLIANCE CANNOT BE DETERMINED. CAUSAL RELATIONSHIP CANNOT BE ESTABLISHED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WHO WAS PLACED IN THE HOLLISTER PREMIER OSTOMY BARRIER EXPERIENCED A FUNGAL SKIN INFECTION UNDER THE BARRIER. IT WAS REPORTED THAT THE ER TOLD HIM TO CHANGE THE BARRIER 4X A DAY AND USE KETOCONAZOLE 2% AND TRIAMCINOLONE.