InjuryEXB
NEW IMAGE CERAPLUS SKIN BARRIER WITH TAPE BORDER
Received Dec 4, 2018 · Event occurred Nov 19, 2018
Report 1119193-2018-00041 · MDR key 8130908
Device
Generic name
New Image Ceraplus Skin Barrier With Tape Border
Manufacturer
Hollister IncorporatedCatalog number
11204
Lot number
UNKNOWN
Product problems
- Use of Device Problem
Patient
75 YR
- Tissue Damage
- Tissue Damage
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 NOT NUMBER NOT KNOWN. SAMPLE REVIEW NOT POSSIBLE BECAUSE NO SAMPLE AVAILABLE. TREND DATA REVIEWED AND NO ADVERSE TREND OBSERVED.
Description of Event or Problem
IT WAS REPORTED THAT AN END USER EXPERIENCED RAW SKIN UNDER THE TAPE PORTION OF THE BARRIER. END USER NEEDED TO BE HOSPITALIZED FOR 2 DAYS TO RECEIVE PAIN SHOTS DURING ROUTINE STOMA CARE.