FDA Adverse Event
Malfunction
Summary report: N
TRUWAVE
MDR report key: 4562167
·
Received December 30, 2014
Report
- Report Number
- 4562167
- Event Type
- Malfunction
- Date Received
- December 30, 2014
- Date of Event
- December 27, 2014
- Report Date
- December 30, 2014
- Manufacturer
- EDWARD LIFESCIENCES LLC
- Product Code
- DXO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MT, US
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 859841 | TRUWAVE | TRANSDUCER, PRESSURE, CATHETER TIP | DXO | EDWARD LIFESCIENCES LLC | * | 59566079 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |