FOCAL ONE

Additional Manufacturer Narrative

WE COULD NOT HAVE ACCESS TO MORE INFORMATION ABOUT THE EVENT (WHEN EXACTLY DID THE FISTULA OCCURRED?) AND ABOUT THE MANAGEMENT OF THE PATIENT'S FISTULA. ANALYSIS OF THE AVAILABLE DATA ENABLED TO CONCLUDE THAT PART OF GOOD PRACTICES WERE NOT RESPECTED BY THE DOCTOR. REGARDING THE DECLARATION OF THIS SERIOUS INCIDENT TO FDA, THE DELAY OF 30 DAYS COULD NOT BE RESPECTED BECAUSE THE PROCESS TO REGISTER FOR THE ELECTRONIC SUBMISSION TOOK SOME TIME, AND WE DIDN'T EXPECT IT.

Description of Event or Problem

A TREATMENT WAS PERFORMED WITH FOCAL ONE ON (B)(6) 2024. ON (B)(6) 2024, AMERICAN SUBSIDIARY INFORMED EDAP TMS FRANCE THAT A FISTULA WAS DIAGNOSED ON THIS PATIENT WHO WAS TREATED IN (B)(6).