InjuryMDA
UNKNOWN CICA CARE
Received May 16, 2017
Report 8043484-2017-00135 · MDR key 6568466
Device
Generic name
Elastomer, Silicone, For Scar Management
Manufacturer
Smith & Nephew Medical Ltd.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Hypersensitivity/Allergic reaction
- Hypersensitivity/Allergic reaction
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A CICA-CARE CAUSED PAIN, BURNING & SWELLING AROUND A SURGICAL SCAR. THE PRODUCT HAD ONLY BEEN IN USE FOR A FEW HOURS, BUT THE AREAS TOOK A MONTH TO HEAL.