PREMIER CONVEX UROSTOMY POUCH WITH PRE-SIZED BARRIER
Received Oct 26, 2021 · Event occurred Aug 20, 2021
Report 1119193-2021-00035 · MDR key 12699118
Device
Generic name
Premier Convex Urostomy Pouch With Pre-sized Barrier
Manufacturer
Hollister IncroporatedCatalog number
8483
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
58 YR
- Itching Sensation
- Rash
- Urticaria
- Itching Sensation
- Rash
- Urticaria
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED. SINCE LOT NUMBER NOT PROVIDED DHR REVIEW NOT POSSIBLE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. PATIENT'S AGE, GENDER, WEIGHT AND RACE NOT KNOWN. ROOT CAUSE OF REPORTED PERISTOMAL SKIN RASH CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WAS USING HOLLISTER PRE-CUT UROSTOMY POUCH AND EXPERIENCED A PERISTOMAL RASH. HE WAS TREATED WITH DAKIN SOLUTION FOR CLEANING, THEN TRIAMCINOLONE SPRAY, AND LASTLY THIN HYDROCOLLOID TO BLOCK THE REACTION FROM THE HOLLISTER BARRIER. THIS SEEMS TO HAVE WORKED. THE PATIENT HAS BEEN SWITCHED TO A DIFFERENT BRAND OF UROSTOMY POUCHES WITH SOME SUCCESS. SYMPTOMS INCLUDED RASH, URTICARIA, AND PRURITUS.