PREMIER CONVEX FLEXTEND TAPE BORDERED UROSTOMY POUCHING SYSTEM
Received May 4, 2022 · Event occurred Apr 26, 2021
Report 1119193-2022-00013 · MDR key 14277761
Device
Generic name
Premier Convex Flextend Tape Bordered Urostomy Pouching System
Manufacturer
Hollister IncroporatedCatalog number
84794
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
64 YR · Male
- Rash
- Rash
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED FOR RASH UNDER THE BARRIER. SINCE LOT NUMBER NOT PROVIDED DHR REVIEW NOT POSSIBLE. NO EVIDENCE THAT THIS A IS LOT-SPECIFIC ISSUE. 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 STARTED DEVELOPING A RASH UNDER THE BARRIER OF HIS HOLLISTER OSTOMY BARRIER ABOUT ONE YEAR AGO. THE END USER REPORTED THAT IT IS A MINOR INCONVENIENCE WHICH THEY MANAGE BY USE OF NYSTATIN POWDER PRESCRIBED BY HIS DOCTOR. HE REPORTED THAT HE USES THE NYSTATIN POWDER ON AND OFF WHENEVER HE EXPERIENCES THE RASH. HOLLISTER CUSTOMER SERVICE IS SENDING HIM OTHER PRODUCTS TO TRIAL.