CICA CARE 6X12CM CTN 1

Additional Manufacturer Narrative

WE HAVE NOW CONCLUDED OUR INVESTIGATION FOR THE COMPLAINT RECEIVED. A VISUAL INSPECTION OF THE RETURNED SAMPLES DID NOT IDENTIFY ANY ISSUES OR ABNORMALITIES WITH THE PRODUCT. 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. DUE TO THE NATURE OF THE REPORTED EVENT, OUR CLINICAL TEAM WERE ASKED TO PERFORM AN INVESTIGATION. THE TEAM CONCLUDED; ¿THE INFORMATION PROVIDED IS INSUFFICIENT TO DETERMINE WHETHER THE PATIENT¿S SYMPTOMS, SIGNS OR OUTCOME ARE DUE TO A PRE-EXISTING OR CONCURRENT MEDICAL OR SURGICAL CONDITION OR PROCEDURE, OR DUE TO AN ADVERSE REACTION TO, OR EXPERIENCE WITH, THE CICA CARE DRESSING, ONE OR MORE OF ITS COMPONENTS, OR ITS INTENDED THERAPEUTIC ACTION. ADDITIONALLY, THE "SURGICAL TAPES", WHICH WERE REPORTEDLY USED FOR ADJUNCTIVE ADHERENCE, COULD NOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR TO THE EVENT. THE PATIENT IMPACT BEYOND THE REPORTED ALLERGY SYMPTOMS AND PRESCRIBED ANTI-ALLERGIC MEDICINE COULD NOT BE DETERMINED BASED ON THE LIMITED INFORMATION PROVIDED. SHOULD CLINICALLY RELEVANT DOCUMENTATION BE PROVIDED, THE CLINICAL ASSESSMENT MAY BE RE-EVALUATED. NO FURTHER MEDICAL ASSESSMENT COULD BE RENDERED AT THIS TIME.¿ A RISK MANAGEMENT REVIEW WAS CARRIED OUT. SKIN SENSITISATION ON PATIENTS WITH FRAGILE OR SENSITIVE SKIN IS CAPTURED WITHIN THE SMITH & NEPHEW RISK FILES FOR THIS PRODUCT. BASED ON THE INFORMATION PROVIDED, THERE ARE NO FURTHER ACTIONS ARE DEEMED NECESSARY AT THIS STAGE. THE IFU FOR THIS PRODUCT OUTLINES THE BELOW ADVERSE EFFECTS MAY IN SOME CASES: SUPERFICIAL MACERATION OF THE SKIN, RASH, PRURITUS. UNFORTUNATELY, DUE TO LIMITED EVENT AND PATIENT INFORMATION IT CANNOT BE CONCLUDED THAT THE CICA CARE PRODUCT CAUSED THE REPORTED SKIN REACTION. THEREFORE, WE HAVE BEEN UNABLE TO DETERMINE A CONCLUSIVE ROOT CAUSE. NO FURTHER ACTIONS BY SMITH & 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.

Description of Event or Problem

IT WAS REPORTED THAT THE CICA CARE WAS APPLIED ON THE SKIN BETWEEN NOSE AND MOUTH FOR SCAR TREATMENT, AND PUT SURGICAL TAPES TO KEEP IT IN POSITION. THE NEXT DAY, THE PATIENT FELT NUMBNESS IN TONGUE AND UNCOMFORTABLE WITH AROUND LUNGS, AND THE SYMPTOMS HAVE STILL CONTINUED ON THE 3RD DAY (TODAY). SHE IS WORRIED THAT IF THE PROBLEMS ARE THE ADVERSE EVENT CAUSING BY CICA CARE. SHE WENT TO SEE A DOCTOR, AND WAS DIAGNOSED WITH ALLERGY SYMPTOMS AND WAS PRESCRIBED ANTI-ALLERGIC MEDICINE. THE UNUSED SAMPLE WILL BE RETURNED FOR INVESTIGATION.