CICA CARE 6X12CM CTN 5
Received Dec 10, 2018 · Event occurred Nov 11, 2018
Report 8043484-2018-00432 · MDR key 8148534
Device
Generic name
Elastomer, Silicone, For Scar Management
Manufacturer
Smith & Nephew Medical Ltd.Catalog number
66320703
Lot number
201731
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
THE ASSOCIATED COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION, PLEASE SEE BELOW THE RESULTS OF OUR INVESTIGATION: WE HAVE NOW CONCLUDED OUR INVESTIGATION INTO THIS COMPLAINT. A REVIEW OF THE ASSOCIATED BATCH MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUE AT THE POINT OF MANUFACTURE WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE ISSUE HIGHLIGHTED BY THE COMPLAINANT. IN ADDITION IT CAN BE CONFIRMED THAT ALL FINISHED PRODUCT SPECIFICATION TESTING WAS SATISFIED AT THE POINT OF RELEASE. NO COMPLAINT SAMPLE WAS AVAILABLE FOR ASSESSMENT. NO CLINICALLY RELEVANT DOCUMENTATION WAS PROVIDED, THEREFORE, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. THE INVESTIGATION DID NOT FIND PRODUCT DEFECT OR MANUFACTURING PROCESS ISSUE SO NO ACTION IS REQUIRED AT PRESENT. ONCE A SAMPLE IS RECEIVED, WE WILL ASSESS AND MAKE FURTHER INVESTIGATION. SMITH AND NEPHEW ACKNOWLEDGE CUSTOMER CONCERN AND ARE CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS. WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF CICA-CARE, THE PATIENT SUFFERED FROM SECOND DEGREE BURNS AT THE PLACE WHERE THE PRODUCT WAS APPLIED.