PREMIER FLEXWEAR DRAINABLE POUCH WITH FILTER AND TAPE BORDER
Received Apr 16, 2019 · Event occurred Mar 8, 2019
Report 1119193-2019-00011 · MDR key 8518471
Device
Generic name
Premier Flexware Drainable Pouch With Filter And Tape Border
Manufacturer
Hollister IncorporatedCatalog number
8081
Lot number
9A132
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
66 YR
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. DHR REVIEW CONDUCTED BASED UPON THE LOT NUMBER PROVIDED AND NO ISSUES IDENTIFIED. TREND DATA REVIEWED AND NO TREND OBSERVED. THE ROOT CAUSE OF THE END USERS GENERALIZED RASH CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER EXPERIENCED A RASH OVER HIS WHOLE BODY AND ITCHING ASSOCIATED WITH THE USE OF THE OSTOMY APPLIANCE. END USER WAS PRESCRIBED HYDROXYZINE PILLS AND INSTRUCTED TO USE HYDROCORTISONE CREAM. HE STATES IT HELPS A LITTLE.