InjuryMDA
CICA CARE
Received Jul 3, 2015 · Event occurred Nov 20, 2014
Report 8043484-2015-00165 · MDR key 4889804
Device
Generic name
Cica Care 12x15cm Ctn 10
Manufacturer
Smith & Nephew Medical (suzhou) LimitedCatalog number
66250707
Lot number
1317
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Skin Discoloration
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AFTER USING THE PRODUCT FOR ONE MONTH, THE SKIN UNDER THE CICA CARE GEL SHEET BECOME DARKER AND A LITTLE DRY WHEN COMPARED WITH THE SURROUNDING SKIN.
Additional Manufacturer Narrative
(B)(4)