KARAYA TAPE BORDERED DRAINABLE POUCH WITH CLAMP, 7/8" PRESIZED OPENING
Received Jul 21, 2020 · Event occurred Nov 1, 2019
Report 1119193-2020-00016 · MDR key 10302010
Device
Generic name
Karaya Tape Bordered Drainable Pouch With Clamp, 7/8" Presized Opening
Manufacturer
Hollister IncorporatedModel number
3228Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
65 YR
- Skin Irritation
- Skin Irritation
Narrative
Additional Manufacturer Narrative
BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. LOT NUMBER NOT PROVIDED SO DHR REVIEW IS NOT POSSIBLE. SAMPLE NOT RETURNED SO A SAMPLE EVALUATION IS NOT POSSIBLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. THE ROOT CAUSE OF THE SKIN IRRITATION UNDER THE TAPE AND BARRIER CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER DEVELOPED SORES AROUND THE STOMA UNDER THE HOLLISTER OSTOMY BARRIER IN (B)(6) 2019 AND WAS PRESCRIBED ORAL ANTIBIOTICS WHICH CLEARED IT UP. SINCE (B)(6), HE HAS BEEN HAVING PROBLEMS WITH SORES AND ULCERS UNDER THE TAPE AND BARRIER PORTION OF THE BARRIER ON AND OFF. HE IS UNDER THE CARE OF A WOCN WHO HAS USED GAUZE PADS WITH SILVER TO APPLY TO THE DEEP ULCERS AND HAS NOW PRESCRIBED STEROID POWDER FOR THE CONTACT DERMATITIS.