KARAYA 5 ONE PIECE PRE-SIZED DRAINABLE OSTOMY POUCH
Received Jul 28, 2020 · Event occurred Jan 1, 2016
Report 1119193-2020-00018 · MDR key 10333346
Device
Generic name
Karaya 5 One Piece Pre-sized Drainable Ostomy Pouch
Manufacturer
Hollister IncorporatedCatalog number
3223
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
43 YR
- Skin Irritation
- Skin Irritation
Narrative
Additional Manufacturer Narrative
TREND DATA REVIEWED AND THIS WAS IDENTIFIED AS AN ISOLATED INCIDENT. BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. DHR REVIEW WAS NOT POSSIBLE BECAUSE LOT NUMBER NOT PROVIDED. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. THE ROOT CAUSE OF THE RECURRING YEAST INFECTIONS CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER HAS BEEN EXPERIENCING RECURRING YEAST INFECTIONS AROUND HER ILEOSTOMY STOMA SINCE 2016. SHE SAYS SHE GETS THE INFECTIONS WHEN SHE SWIMS OR SWEATS. SHE HAS A STANDING ORDER FOR NYSTATIN POWDER WHICH SHE USES WITH STOMA POWDER AND IT CLEARS IT UP. SHE HAS BEEN PUT IN TOUCH WITH HOLLISTER CUSTOMER SERVICE TO SEE IF THERE IS A PRODUCT THAT BETTER MEETS HER NEEDS.