InjuryMDA
CICA-CARE 15CM X 12CM CTN 1
Received Jul 19, 2017 · Event occurred Jun 23, 2017
Report 8043484-2017-00175 · MDR key 6724246
Device
Generic name
Elastomer, Silicone, For Scar Management
Manufacturer
Smith & Nephew Medical Ltd.Model number
66250706Catalog number
66250706
Lot number
201635
Product problems
- Difficult to Remove
- Difficult to Remove
- Insufficient Device Problem Information
Patient
Not reported
- Purulent Discharge
- Tissue Damage
- Injury
- No Code Available
- Purulent Discharge
- Tissue Damage
- Injury
- No Code Available
Narrative
Description of Event or Problem
IT WAS REPORTED PATIENT HAD SKIN PEELING WHEN REMOVED THE DRESSING FROM THE SKIN. WHEN CICA CARE WAS REMOVED, THE SKIN WAS PULLED AND HAS PEELED OFF, IT WAS CONFIRMED THE EXUDATE FLUID FROM THE SKIN PEELING AREA.
Additional Manufacturer Narrative
(B)(4).