FDA Adverse Event
Injury
Summary report: N
PIEZOSURGERY
MDR report key: 8320979
·
Received February 8, 2019
Report
- Report Number
- 3003933619-2018-00002
- Event Type
- Injury
- Date Received
- February 8, 2019
- Date of Event
- April 23, 2018
- Report Date
- June 7, 2018
- Manufacturer
- MECTRON S.P.A.
- Product Code
- JDX
- PMA / PMN Number
- K091227
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE MANUFACTURER REQUIRED TO THE HOPITAUX THE TOULOSE TO RETURN THE DEVICE TO DO THE RELATED INVESTIGATION. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem · 0
THE CUSTOMER INDICATES: BURNS THE MUCOSA OF THE LOWER LEFT LIP THAT IMMEDIATELY REACHES THE POINT OF EATHING DESPITE IRRIGATION. THE HANDPIECE MUST BE REPAIRED. CONSEQUENCES;: PROLUNGATION OF SURGERY.
Additional Manufacturer Narrative · 1
THE MANUFACTURER REQUIRED TO THE (B)(6) TO RETURN THE DEVICE TO DO THE RELATED INVESTIGATION. THE DEVICE WAS NOT RETURNED.
Description of Event or Problem · 1
THE CUSTOMER INDICATES: BURNS THE MUCOSA OF THE LOWER LEFT LIP THAT IMMEDIATELY REACHES THE POINT OF EATING DESPITE IRRIGATION. THE HANDPIECE MUST BE REPAIRED. CONSEQUENCES;: PROLONGATION OF SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114809 | PIEZOSURGERY | PIEZOSURGERY 3 | JDX | MECTRON S.P.A. | 02890008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR |