FDA Adverse Event
Other
Summary report: N
TARGIS MDS
MDR report key: 651466
·
Received December 7, 2005
Report
- Report Number
- 2133936-2005-00008
- Event Type
- Other
- Date Received
- December 7, 2005
- Report Date
- December 6, 2005
- Manufacturer
- UROLOGIX, INC.
- Product Code
- MEQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
REPORTER INDICATED THAT THE PATIENT IS NOW "INCONTINENT OF URINE AND IMPOTENT." PATIENT RECEIVED A TARGIS TREATMENT IN 2004.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGIS MDS | HYPOTHERMIA MICROWAVE/RF SYSTEM FOR BPH | MEQ | UROLOGIX, INC. | * | M001546 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Other |