FDA Adverse Event
Malfunction
Summary report: N
EXABLATE 2000
MDR report key: 1557317
·
Received November 29, 2009
Report
- Report Number
- 9615058-2009-00001
- Event Type
- Malfunction
- Date Received
- November 29, 2009
- Date of Event
- September 15, 2009
- Report Date
- September 15, 2009
- Manufacturer
- INSIGHTEC, LTD.
- Product Code
- NRZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXABLATE 2000 | MRGFUS | NRZ | INSIGHTEC, LTD. | 2000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |