CICA-CARE 15CM X 12CM CTN 1

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE PRODUCT, THE PATIENT SUFFERED FROM AN INFECTION.

Additional Manufacturer Narrative

WE HAVE NOW CONCLUDED OUR INVESTIGATION FOR THE COMPLAINT RECEIVED. NO DHR/BATCH RECORD REVIEW POSSIBLE AS NO LOT NUMBERS HAVE BEEN MADE AVAILABLE. HOWEVER, A REVIEW OF THE DATABASE OF CHANGE CONTROLS FOR THE CICA-CARE PRODUCT FAMILY WAS REVIEWED AND IT WAS FOUND THERE WERE NO CHANGES TO RAW MATERIALS, MANUFACTURING METHODS OR EQUIPMENT SINCE THE ORIGINAL QUALIFICATION EXERCISES THAT COULD HAVE CONTRIBUTED TO THE ISSUE EXPERIENCED BY THE CUSTOMER OR ALLEGED ADVERSE REACTION A COMPLAINT SAMPLE WAS NOT AVAILABLE FOR ASSESSMENT. A COMPLAINT HISTORY REVIEW IS ATTACHED FOR PERIOD 2016-2019 AND A REVIEW OF OUR DATABASE HAS FOUND THIS COMPLAINT TO BE THE ONLY COMPLAINT RECEIVED FOR THIS ISSUE FOR THIS PRODUCT CODE AND LOT NUMBER THEREFORE THIS IS DEEMED AN ISOLATED INCIDENT. NO RELEVANT CLINICAL MEDICAL INFORMATION WAS PROVIDED TO CONDUCT A THOROUGH MEDICAL ASSESSMENT. THE INVESTIGATION DID NOT FIND PRODUCT DEFECT OR MANUFACTURING PROCESS ISSUE SO NO ACTION IS REQUIRED AT PRESENT. IF A SAMPLE BECOMES AVAILABLE, THE COMPLAINT MAY BE REOPENED FOR 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.