UNKN CICA-CARE GEL
Received Jan 22, 2021 · Event occurred Jan 3, 2021
Report 8043484-2021-00157 · MDR key 11218041
Device
Generic name
Elastomer, Silicone, For Scar Management
Manufacturer
Smith & Nephew Medical Ltd.Catalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Rash
- Rash
Narrative
Additional Manufacturer Narrative
THE DEVICE USED IN TREATMENT WAS NOT RETURNED FOR EVALUATION, ALL PROVIDED INFORMATION HAS BEEN REVIEWED AND WE HAVE NOT BEEN ABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE REPORTED EVENT OR DETERMINE A ROOT CAUSE. PROBABLE ROOT CAUSES ARE INCLUDE, APPLICATION, REMOVAL, TIME LEFT ON PATIENT, TRAUMA, MATERIALS USED WITHIN THE DRESSING. THE IFU HAS BEEN REVIEWED AND CONTAINS COMPREHENSIVE INSTRUCTIONS ON THE SAFE OPERATION AND USE OF THE DEVICE. THE ASSOCIATED RISK FILES CONTAIN DETAILS RELATING TO HARM. HOWEVER, THE CLINICAL REVIEW HAS NOT ESTABLISHED A CAUSAL LINK. ADDITIONAL RMR IS NOT REQUIRED. NO BATCH/LOT NUMBER HAS BEEN PROVIDED, THEREFORE A REVIEW OF THE DEVICE HISTORY HAS NOT BEEN POSSIBLE THE COMPLAINT HISTORY FILE CONTAINS FURTHER INSTANCES. THIS INVESTIGATION IS NOW COMPLETE WITH NO FURTHER ACTION DEEMED NECESSARY. SMITH + NEPHEW WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A HEALTH CARE PROFESSIONAL WAS TREATING A PATIENT WHO HAS UNDERGONE SURGERY AFTER A WRIST FRACTURE. HIS SCAR WAS QUITE RAISED AND PUCKERED SO WAS PRESCRIBED CICA GEL STRIPS TO REDUCE THE SCAR. HOWEVER HE HAS HAD ALLERGIC REACTION TO THE GEL STRIPS (SMALL RED LUMPS). THE PATIENT WAS TREATED WITH CORTISONE CREAM TO SOLVE THE ADVERSE EVENT.