LEUKOSTRIP 6.4X102MM CTN 50

Description of Event or Problem

IT WAS REPORTED THAT ON MULTIPLE APPLICATIONS DURING A TEST, THE LEUKOSTRIP BEGIN TO LIFT UP/ROLL UPWARDS CIRCA 1-2MM, AFTER TWO HOURS. LEUKOSTRIP WAS REMOVED AND A COMPETITOR'S PRODUCT WAS USED. THERE WAS NO DELAY. NO PATIENT HARM REPORTED.

Additional Manufacturer Narrative

H3, H6: THE DEVICE, USED IN TREATMENT, HAS BEEN RETURNED AND EVALUATED. A VISUAL AND FUNCTIONAL EVALUATION FOUND NO FAULTS. THERE WAS NO RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT AND NO ROOT CAUSE WAS DETERMINED. PROBABLE CAUSE INCLUDES, SKIN PREPARATION AND WOUND CARE, THE IFU OFFERS FURTHER GUIDANCE. MEDICAL REVIEW CONCLUDED: NO PATIENT HARM WAS REPORTED, THE STERI-STRIPS WERE USED AS REPLACEMENTS FOR THE LEUKOSTRIP. SINCE NO ADVERSE EVENTS ARE BEING REPORTED DUE TO THE REPORTED, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED. A REVIEW OF THE ASSOCIATED BATCH MANUFACTURING RECORDS CONFIRMED THAT THE DEVICE MET MANUFACTURING SPECIFICATIONS AT THE POINT OF RELEASE. THE COMPLAINT HISTORY REVIEW FOUND FURTHER INSTANCES OF THE REPORTED EVENT IN THE PAST YEARS. THE ASSOCIATED RISK FILES CONTAIN DETAILS RELATING TO HARM. HOWEVER, NO HARM HAS BEEN ALLEGED. THE INSTRUCTIONS FOR USE PROVIDE COMPREHENSIVE INSTRUCTIONS OF THE OPERATION, USE AND LIMITATIONS OF THE DEVICE. THIS INVESTIGATION IS NOW COMPLETE WITH NO FURTHER ACTION DEEMED NECESSARY. SMITH + NEPHEW WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.