CICA CARE 12X6CM - CN RETAIL CTN 1

Additional Manufacturer Narrative

INTERNAL REFERENCE NUMBER: CASE (B)(4)

Description of Event or Problem

IT WAS REPORTED THAT, AFTER USING BOTH A CICA CARE 12X6CM - CN RETAIL CTN 1 AND A CICA-CARE GEL 15G - CHINA FOR TEN DAYS, THE PATIENT'S WOUND BECAME SEPTIC, SWOLLEN, AND PAINFUL AS A RESULT. IT REMAINS UNCLEAR HOW THIS ADVERSE EVENT WAS SOLVED AND/OR TREATED. THE PATIENT'S CURRENT HEALTH STATUS REMAINS UNKNOWN.

Additional Manufacturer Narrative

H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PHOTO SUPPLIED HAS BEEN OBSERVED AND CONFIRMED THE WOUND WAS RED. THE COMPLAINT PROBLEM MAY BE ATTRIBUTED TO EITHER POOR HYGIENE OR TO THE PRODUCT BEING APPLIED WITH PRESSURE TOO TIGHTLY. THE BATCH RECORD WAS REVIEWED AND IT COULD BE CONFIRMED THAT THE PRODUCTS HAD PROGRESSED THROUGH A SATISFACTORY RELEASE PROCESS WHICH INVOLVED TESTING THE PRODUCT AGAINST THE REQUIREMENTS OF THE FINISHED PRODUCT SPECIFICATION. THERE WAS ALSO NO ANY ISSUE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT PROBLEM. THE COMPLAINT HISTORY REVIEW CONFIRMS ONE PREVIOUS COMPLAINT OF THIS NATURE, WITH NO MANUFACTURING PROBLEM OBSERVED. A REVIEW OF PRIOR ESCALATION ACTIONS FOUND NO ACTIONS APPLICABLE TO THE SCOPE OF THIS CASE. THIS CASE REPORTS THAT AFTER USING CICA-CARE FOR TEN DAYS, THE PATIENT¿S WOUND BECAME SEPTIC, SWOLLEN, AND PAINFUL. THE PROVIDED PHOTO SHOWS THE REDNESS TO THE AREA. HOWEVER, THE PHOTO ALONE DOES NOT PROVIDE ANY CLINICAL INSIGHT INTO THE REPORTED SYMPTOMS. IT WAS NOTED WITHIN THE ATTACHMENTS THAT THE PATIENT REPORTED A LOCAL INFECTION AND THERE WAS NO ADDITIONAL INFORMATION TO SUPPORT A DIAGNOSIS OF SEPSIS. THE INFORMATION PROVIDED IS INSUFFICIENT TO DETERMINE WHETHER THE PATIENT¿S SYMPTOMS, ARE DUE TO A PRE-EXISTING OR CONCURRENT MEDICAL OR SURGICAL CONDITION OR PROCEDURE. IT CANNOT BE DEFINITIVELY CONCLUDED THAT THE ROOT CAUSE OF THE REPORTED EVENTS IS THE DIRECT RESULT OF USING THE CICA-CARE PRODUCT. THE PATIENT IMPACT COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. SHOULD ANY ADDITIONAL CLINICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-EVALUATED. NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. A RISK MANAGEMENT REVIEW CONCLUDED THAT THE ALLEGED FAILURE MODE AND ANY ASSOCIATED HARM HAS BEEN ANTICIPATED WITHIN THE RISK FILE, WITH NO UPDATES REQUIRED. THIS INVESTIGATION IS NOW COMPLETE WITH NO FURTHER ACTION DEEMED NECESSARY. SMITH AND NEPHEW WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE. ADDITIONAL INFORMATION: B1, B2, D5, D7A, D8, E1 (ADDRESS), E2. CORRECTED DATA: E1 (REPORTED AND FACILITY NAME), G2, H6 (HEALTH EFFECT - CLINICAL CODE AND HEALTH EFFECT - IMPACT CODE)