PREMIER CONVEX FLEXTEND UROSTOMY POUCHING SYSTEM
Received Mar 8, 2022 · Event occurred Feb 7, 2022
Report 1119193-2022-00007 · MDR key 13694364
Device
Generic name
Premier Convex Flextend Urostomy Pouching System
Manufacturer
Hollister IncroporatedCatalog number
8485
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
74 YR · Male
- Rash
- Skin Inflammation/ Irritation
- Rash
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
TREND ANALYSIS CONDUCTED AND NO ADVERSE TRENDS OBSERVED FOR TAPE BORDER OR POUCH FILM CAUSING SKIN IRRITATION OR ALLERGIC REACTION. SINCE LOT NUMBER NOT PROVIDED DHR REVIEW NOT POSSIBLE. SAMPLE NOT RETURNED SO SAMPLE EVALUATION NOT POSSIBLE. ROOT CAUSE OF REPORTED IRRITATION/RASH UNDER THE FILM AND TAPE BORDER CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT ABOUT 1 YEAR AGO AN END USER STARTED EXPERIENCING AN IRRITATION/RASH UNDER THE TAPE BORDER OF HIS OSTOMY APPLIANCE AND UNDER THE POUCH FILM THAT TOUCHES HIS SKIN. HE REPORTED THAT ABOUT 1 MONTH AGO HE WENT TO HIS DOCTOR ABOUT THE IRRITATION AND THE DOCTOR PRESCRIBED 0.1% TRIAMCINOLONE ACETONIDE CREAM. HE SAID THE DOCTOR BELIEVES IT TO BE AN ALLERGY. HE FURTHER REPORTED THAT THE DOCTOR DID NO MORE TESTING AND THE END USER DOES NOT HAVE A FOLLOW UP APPOINTMENT SCHEDULED WITH THE DOCTOR. THE END USER CONTINUED TO REPORT THAT HE IS USING THIS CREAM SPARINGLY AND IT CLEARS UP THE AREA BUT WHEN HE STOPS USING IT, THE RASH RETURNS. END USER IS WORKING WITH HOLLISTER CUSTOMER SERVICE TO TRY OTHER HOLLISTER PRODUCTS TO SAMPLE.