NEW IMAGE FLEXWEAR TAPE BORDERED BARRIER, CUT TO FIT
Received Jul 14, 2020 · Event occurred Jun 1, 2020
Report 1119193-2020-00015 · MDR key 10272037
Device
Generic name
New Image Flexwear Tape Bordered Barrier, Cut To Fit
Manufacturer
Hollister IncorporatedModel number
14204Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
58 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. END USER'S WEIGHT NOT PROVIDED SO ESTIMATION USED. THE ROOT CAUSE OF THE SKIN IRRITATION CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER DEVELOPED A RASH UNDER AND BEYOND PART OF THE TAPE AREA OF THE HOLLISTER OSTOMY BARRIER. HIS DOCTOR PRESCRIBED TOPICAL CREAM CONTAINING CLORTRIMAZOLE AND BETAMETHASONE. THE CREAM IS WIPED OFF BEFORE APPLYING THE BARRIER IN ORDER TO ALLOW THE BARRIER AND TAPE TO ADHERE. THE RASH HAS NOT CLEARED UP YET SO HE WILL BE SEEING A MEDICAL PROFESSIONAL AGAIN.