InjuryEXB
NEW IMAGE FLEXWEAR CUT TO FIT SKIN BARRIER WITHOUT TAPE BORDER
Received Oct 29, 2019 · Event occurred Aug 24, 2019
Report 1119193-2019-00038 · MDR key 9250813
Device
Generic name
New Image Flexwear Cut To Fit Skin Barrier Without Tape Border
Manufacturer
Hollister IncorporatedModel number
15203Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
40 YR
- Erythema
- Erythema
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.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER EXPERIENCED SEVERE REDNESS AND SKIN BUMPS UNDER THE HOLLISTER OSTOMY BARRIER. NYSTATIN CREAM WAS PRESCRIBED. IT IS HELPING A LITTLE BUT NOT COMPLETELY.