CICA CARE 6X12CM CTN 1
Received Aug 18, 2020 · Event occurred Jul 23, 2020
Report 8043484-2020-02530 · MDR key 10423699
Device
Generic name
Elastomer, Silicone, For Scar Management
Manufacturer
Smith & Nephew Medical Ltd.Catalog number
66250704
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- Foreign Body Reaction
- Foreign Body Reaction
Narrative
Additional Manufacturer Narrative
H3, H6: 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 CAUSES INCLUDE TIME LEFT ON PATIENT, TRAUMA, MATERIALS USED WITHIN THE DRESSING. THE ASSOCIATED RISK FILES CONTAIN THE REPORTED FAILURE/HARM OR EVENT. HOWEVER, THE CLINICAL REVIEW HAS NOT ESTABLISHED A CAUSAL LINK. ADDITIONAL RMR IS NOT REQUIRED. THE INSTRUCTIONS FOR USE HAVE BEEN REVIEWED AND CONTAINS COMPREHENSIVE INSTRUCTIONS ON THE SAFE OPERATION AND USE OF THE DEVICE 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.
Description of Event or Problem
IT WAS REPORTED THAT 2 MONTHS AFTER AN OPERATION, WHILE APPLYING CICA CARE 6X12CM, THE PATIENT¿S KELOID BECOME ACTIVE AFTER 2 MONTHS OF USAGE.