FDA Adverse Event
Injury
Summary report: N
THORATEC PVAD
MDR report key: 2920574
·
Received January 17, 2013
Report
- Report Number
- 2920574
- Event Type
- Injury
- Date Received
- January 17, 2013
- Report Date
- January 16, 2013
- 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
RVAD PVAD HOUSING WAS CRACKED AND LEAKING AIR. IT WAS EXCHANGED IN THE OPERATING ROOM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 26310 | THORATEC PVAD | BIVAD | DSQ | THORATEC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |