CICA CARE 12X6CM - CN RETAIL CTN 1

Additional Manufacturer Narrative

WE HAVE NOW CONCLUDED OUR INVESTIGATION FOR THE COMPLAINT RECEIVED. 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. A COMPLAINTS HISTORY REVIEW WAS CARRIED OUT USING THE LOT AND PART NUMBER PROVIDED, THERE HAS BEEN FURTHER COMPLAINTS REPORTED WITH THIS FAILURE MODE IN THE PAST THREE YEARS. THE INSTRUCTIONS FOR USE PROVIDE COMPREHENSIVE INSTRUCTIONS OF THE OPERATION, USE AND LIMITATIONS OF THE DEVICE. THE MEDICAL REVIEW COULD NOT ESTABLISH A LINK BETWEEN THE PRODUCT AND HARM WITHIN THIS COMPLAINT AND THEREFORE ADDITIONAL RISK MANAGEMENT REVIEW IS NOT REQUIRED. A CLINICAL INVESTIGATION WAS CARRIED OUT. IT WAS CONCLUDED: ¿BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IT COULD NOT BE DETERMINED BY THE PHOTOS ALONE IF THE SKIN DARKENING WAS A REACTION TO THE ADHESIVE IN THE SILICONE GEL FILM, PRODUCTS APPLIED OR THE RESULT OF A USER ERROR. IN THE ¿HOW TO USE CICA-CARE¿ DIRECTIONS IT NOTES ¿DO NOT HOLD THE GEL SHEET TOO TIGHTLY TO THE SKIN AS THIS MAY CAUSE IRRITATION OF THE SCAR AND SURROUNDING AREA.¿ IT IS ALSO UNKNOWN IF ALL THE ADHESIVE RESIDUE WAS REMOVED FROM THE PATIENT¿S SKIN IN BETWEEN USE AS IT WAS STATED THAT WATER WAS USED FOR CLEANING, AND THE INSTRUCTIONS NOTE TO USE A MILD-SOAP WHEN CLEANING. IT WAS COMMUNICATED VIA E-MAIL THAT THE SKIN HAS IMPROVED SINCE CHANGING DRESSINGS. SINCE NO FURTHER HARM IS ANTICIPATED NO FURTHER CLINICAL ASSESSMENT IS WARRANTED AT THIS TIME.¿ THE DEVICE WAS USED FOR TREATMENT. AS NO SAMPLES WERE RETURNED A PRODUCT EVALUATION COULD NOT BE CARRIED OUT. WE HAVE NOT BEEN ABLE TO CONFIRM A RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE OR IDENTIFY A ROOT CAUSE ON THIS OCCASION. NO FURTHER ACTIONS BY SMITH AND NEPHEW ARE DEEMED NECESSARY AT THIS STAGE. HOWEVER, WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE. SMITH AND NEPHEW ACKNOWLEDGE CUSTOMER CONCERN AND ARE CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS.

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT AFTER TWO DAYS OF USING THE CICACARE DRESSING ON AN INFANT'S CHEEK FOR TREATMENT OF A SCAR, THE SKIN UNDER THE DRESSING TURNED DARK. AFTER NOTICING THIS, THE PATIENT STOPPED USING THE DRESSING AND STARTED USING A COMPETITOR PRODUCT TO TREAT THE SCAR. THE SKIN STAIN HAS IMPROVED EVER SINCE. THE PATIENT HAD BEEN USING CICACARE CONTINUOUSLY SINCE (B)(6) 2020. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.