NEW IMAGE TWO-PIECE POUCHING SYSTEM
Received Dec 3, 2019 · Event occurred Nov 18, 2019
Report 1119193-2019-00043 · MDR key 9401991
Device
Generic name
New Image Flexwear Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
14203
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
40 YR
- Tissue Breakdown
- Tissue Breakdown
Narrative
Additional Manufacturer Narrative
BIOCOMPATIBILITY TESTING HAS BEEN PERFORMED IN ACCORDANCE WITH ISO 10993 AND MATERIALS WERE FOUND TO BE NON-SENSITIZERS. DHR REVIEW NOT POSSIBLE BECAUSE LOT NUMBER NOT KNOWN. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED. THE ROOT CAUSE OF THE REPORTED BLISTERS UNDER THE SKIN BARRIER CANNOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT THE END USER EXPERIENCED OPEN BLISTERS, EXTENDING BEYOND THE EDGES OF THE BARRIER AFTER USING 7917 SKIN GEL PROTECTIVE WIPES ALONG WITH THIS 14203 BARRIER. THE END USER WAS TREATED WITH ORAL PREDNISONE, NYSTATIN POWDER AND NEOSPORIN. END USER WILL BE SENT SAMPLES OF ANOTHER BARRIER PRODUCT TO TRY.