CICA CARE 12X15CM CTN 10

Additional Manufacturer Narrative

H3, H6: WE HAVE NOW CONCLUDED OUR INVESTIGATION FOR THE COMPLAINT RECEIVED. THE DEVICE INTENDED TO BE USED IN TREATMENT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL EVALUATION DID NOT CONFIRM A RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE. FACTORS THAT CAN CONTRIBUTE TO THE REPORTED EVENT INCLUDE INSUFFICIENT CLEANING AND DRYING OF THE SCAR AND SURROUNDING SKIN. THE MANUFACTURING RECORDS SHOW NO EVIDENCE THAT THE PRODUCT DID NOT MEET SPECIFICATION AT THE TIME OF MANUFACTURE. THE INSTRUCTIONS FOR USE PROVIDE COMPREHENSIVE INSTRUCTIONS OF THE OPERATION, USE AND LIMITATIONS OF THE DEVICE. THE CLINICAL EVALUATION CONCLUDED: THIS CASE REPORTS THAT THE CICA CARE DRESSING FELL OFF WHEN BEING USED FOR HYPERTROPHIC SCAR TREATMENT. NO PATIENT HARM OCCURRED DUE TO THE USE OF THE DRESSING. SINCE NO HARM TO THE PATIENT IS BEING REPORTED NO FURTHER MEDICAL ASSESSMENT IS WARRANTED. THE ASSOCIATED RISK FILES CONTAIN THE REPORTED FAILURE, WITH NO ADDITIONAL ACTIONS NECESSARY. THE COMPLAINT HISTORY FILE CONTAINS FURTHER INSTANCES OF THE REPORTED EVENT, HOWEVER THIS INVESTIGATION IS NOW COMPLETE WITH NO FURTHER ACTION DEEMED NECESSARY AT THIS STAGE. 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.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING TREATMENT THE PRODUCT WAS NOT ADHESIVE AND FELL OFF. THE PRODUCT WAS NO LONGER USED AFTER IT DROPPED OFF AND THE THERAPY WAS NOT COMPLETED. NO HARM OR INJURY REPORTED.