FDA Adverse Event
Malfunction
Summary report: N
PRIMEWIRE PRESTIGE PLUS
MDR report key: 3131012
·
Received May 16, 2013
Report
- Report Number
- 3131012
- Event Type
- Malfunction
- Date Received
- May 16, 2013
- Date of Event
- May 10, 2013
- Report Date
- May 16, 2013
- Manufacturer
- VOLCANO CORPORATION
- Product Code
- DQX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 218545 | PRIMEWIRE PRESTIGE PLUS | WIRE, GUIDE, CATHETER | DQX | VOLCANO CORPORATION | * | 11050091050 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |