FDA Adverse Event
Injury
Summary report: N
ESX
MDR report key: 4645791
·
Received February 9, 2015
Report
- Report Number
- 1032227-2015-00004
- Event Type
- Injury
- Date Received
- February 9, 2015
- Date of Event
- November 1, 2014
- Report Date
- February 6, 2014
- Manufacturer
- FKG DENTAIRE SA
- Product Code
- EKS
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- OR, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
THE FIRST PASS OF THE EXPEDITOR FILE SEPARATED AND WAS UNABLE TO RETRIEVE IT. SO NOW THE DOCTOR MUST DO A ROOT AMP. .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 91731 | ESX | ENDODONTIC FILE (EXPEDITOR) | EKS | FKG DENTAIRE SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |