FDA Adverse Event
Injury
Summary report: N
THORATEC PVAD
MDR report key: 2771052
·
Received October 3, 2012
Report
- Report Number
- 2771052
- Event Type
- Injury
- Date Received
- October 3, 2012
- Date of Event
- November 19, 2008
- Report Date
- October 2, 2012
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT HAS A BIVAD, RIGHT CANNULA THROMBUS (STRING). RESOLVED (B)(6) 2008. DR.(B)(6) HAS SPECIFIED THAT THROMBUS IS NOT A DEVICE MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THORATEC PVAD | BIVAD | DSQ | THORATEC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |