FDA Adverse Event
Malfunction
Summary report: N
MAMMOVISION
MDR report key: 5409839
·
Received November 25, 2003
Report
- Report Number
- 1418957-2003-00006
- Event Type
- Malfunction
- Date Received
- November 25, 2003
- Date of Event
- October 15, 2003
- Report Date
- November 24, 2003
- Manufacturer
- FISCHER IMAGING CORP.
- Product Code
- NEU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAMMOVISION | BREAST BIOPSY SYSTEM | NEU | FISCHER IMAGING CORP. | 85450G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |