FDA Adverse Event
Malfunction
Summary report: N
PROSTATRON
MDR report key: 503788
·
Received December 9, 2003
Report
- Report Number
- 2133936-2003-00023
- Event Type
- Malfunction
- Date Received
- December 9, 2003
- Date of Event
- September 11, 2003
- Report Date
- September 23, 2003
- Manufacturer
- UROLOGIX, INC.
- Product Code
- MEQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- INVALID DATA
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROSTATRON | HYPERTHERMIA MICROWAVE/RF SYSTEM | MEQ | UROLOGIX, INC. | 410053-004 | 530365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |