FDA Adverse Event
Injury
Summary report: N
FOCAL ONE
MDR report key: 20985956
·
Received December 20, 2024
Report
- Report Number
- 3002806876-2024-00001
- Event Type
- Injury
- Date Received
- December 20, 2024
- Date of Event
- October 24, 2024
- Report Date
- November 26, 2024
- Manufacturer
- EDAP TMS
- Product Code
- PLP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
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 · 0
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).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2203565 | FOCAL ONE | FOCAL ONE | PLP | EDAP TMS | 239320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Other |