FDA Adverse Event
Injury
Summary report: N
PROSTATRON
MDR report key: 312827
·
Received January 16, 2001
Report
- Report Number
- 2133936-2001-00001
- Event Type
- Injury
- Date Received
- January 16, 2001
- Date of Event
- March 26, 1999
- Report Date
- January 16, 2001
- Manufacturer
- UROLOGIX, INC.
- Product Code
- MEQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
UROLOGIX REC'D A MEDWATCH REPORT FORM FROM THE FDA ON 01/10/2001 (MW1020463). UROLOGIX DID NOT RECEIVE ENOUGH INFORMATION FROM THE MEDWATCH REPORT (MW1020463) TO INVESTIGATE THIS EVENT FURTHER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1683 | PROSTATRON | HYPERTHERMIA, RF/MICROWAVE SYSTEM | MEQ | UROLOGIX, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |