FDA Adverse Event
Malfunction
Summary report: N
RADIFOCUS GLIDEWIRE
MDR report key: 1040923
·
Received March 27, 2008
Report
- Report Number
- 9681834-2008-00006
- Event Type
- Malfunction
- Date Received
- March 27, 2008
- Report Date
- February 27, 2008
- Manufacturer
- TERUMO CORP, ASHITAKA
- Product Code
- DQX
- PMA / PMN Number
- K955801
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIFOCUS GLIDEWIRE | GUIDEWIRE | DQX | TERUMO CORP, ASHITAKA | NA | 071011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |